You asked, we answered: 8 key questions about the Wisconsin football team's COVID-19 outbreak - Madison.com

1. You asked, we answered: 8 key questions about the Wisconsin football team's COVID-19 outbreak  Madison.com
2. Halftime Highlights: Michigan State leads at the Half | Big Ten Football  Big Ten Network
3. Dan Patrick reports that Michigan and OSU want Nebraska to play  247Sports
4. Nugent: When it comes to winning a division Wisconsin did the right thing this week  WOWT
5. Breaking: A Second Big Ten Starting QB Has Tested Positive  The Spun
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You asked, we answered: 8 key questions about the Wisconsin football team's COVID-19 outbreak - Madison.com

1. You asked, we answered: 8 key questions about the Wisconsin football team's COVID-19 outbreak  Madison.com
2. Dan Patrick reports that Michigan and OSU want Nebraska to play  247Sports
3. Ohio State's Wide Receivers Are Turning Heads | Big Ten Football | Urban Analysis  Big Ten Network
4. Nugent: When it comes to winning a division Wisconsin did the right thing this week  WOWT
5. Why was Wisconsin vs. Nebraska canceled? Badgers' COVID-19 outbreak alters Big Ten schedule  Sporting News
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Regeneron halts trial of COVID-19 antibody drug in sickest hospitalized patients | TheHill - The Hill

1. Regeneron halts trial of COVID-19 antibody drug in sickest hospitalized patients | TheHill  The Hill
2. Trial of Regeneron’s Covid-19 Antibody Drug Is Halted in Sickest Hospital Patients  The Wall Street Journal
3. 2nd study testing a COVID-19 antibody drug has a setback  Yahoo News
4. Covid toes could last for 150 days, new research finds  NBC News
5. Could your smartwatch help detect the next COVID-19 outbreak? San Diego scientists think so  The San Diego Union-Tribune
6. View Full Coverage on Google News

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October 28, 2020 at 03:27PM Influenza neuraminidase antigenicity and efficacy in vaccines

Robert Daniels' research project "Influenza neuraminidase antigenicity and efficacy in vaccines".

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October 30, 2020 at 04:21PM Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy

Giving yourself too much or too little oxygen can be dangerous. If you are using a pulse oximeter to monitor your oxygen levels and think they are low, see a doctor. You should not use an oxygen concentrator at home unless it has been prescribed by a health care provider.

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October 30, 2020 at 04:48PM FDA Patient Engagement Partnerships

FDA Patient Engagement Partnerships

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October 30, 2020 at 03:07PM General Biologics, Notices, Proposed and Final Rules

General Biologics, Notices, Proposed and Final Rules

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October 30, 2020 at 01:51PM Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs

In consultation with other federal partners, FDA has developed a list of drug and biological product essential medicines, drug, biological product, and device medical countermeasures, and critical inputs, as required by Executive Order 13944. FDA welcomes public comment on this list.

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Nebraska Keeps Defying the Big Ten, Responding to Adversity With Petulance - Sports Illustrated

1. Nebraska Keeps Defying the Big Ten, Responding to Adversity With Petulance  Sports Illustrated
2. Nebraska's official radio account deletes controversial tweet  247Sports
3. Discussing Wisconsin canceling game vs. Nebraska after outbreak of COVID-19 cases | Get Up  ESPN
4. Badgers football has three new positive tests  WKOW
5. Louisville basketball: A quick preview of Cards’ match up with Wisconsin  Big Red Louie
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France terror attack: 3 dead in Nice could roil debate over free speech and Islam - Vox.com

1. France terror attack: 3 dead in Nice could roil debate over free speech and Islam  Vox.com
2. Macron Puts France in New Nationwide Lockdown  Bloomberg Politics
3. France will not give in to terror after Nice attack, Macron says  The Guardian
4. Europe outbreak worsens, France and Germany lock down, US close behind - Business Insider  Business Insider
5. Offensive Charlie Hebdo cartoon pushes Turkey-France tensions into overdrive.  NBC News
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October 29, 2020 at 06:04PM CBER Biologics Effectiveness and Safety (BEST) System

This is the main page for CBER's Biologics Effectiveness and Safety (BEST) System.

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October 29, 2020 at 06:04PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

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October 29, 2020 at 06:04PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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October 28, 2020 at 12:37PM Diseases transmitted by wildlife: what are the priorities in terms of policy and investment?

How do diseases spread from wildlife to humans? What can be done to limit the risks and the impact on society? A white paper and a policy brief suggest ways of preventing and detecting diseases, and taking rapid action if necessary. Both documents were produced as part of the Sustainable Wildlife Management (SWM) programme, in which CIRAD is a partner, and presented at the Global Landscapes Forum on 28 October 2020.

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Nebraska's official radio account asked readers if Big Ten rules would apply to the Huskers - Awful Announcing

1. Nebraska's official radio account asked readers if Big Ten rules would apply to the Huskers  Awful Announcing
2. "Discussing the Impact of Wisconsin-Nebraska COVID Cancellation" | Big Ten Football  Big Ten Network
3. Wisconsin cancels football game vs. Nebraska after outbreak of COVID-19 cases  ESPN
4. Progress has been hard to come by for Scott Frost's Nebraska Cornhuskers  Madison.com
5. Paul Chryst opens up on potential origin of virus outbreak  247Sports
6. View Full Coverage on Google News

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Dr. Anthony Fauci says U.S. is in a 'bad position' as daily coronavirus cases hit record highs - CNBC

1. Dr. Anthony Fauci says U.S. is in a 'bad position' as daily coronavirus cases hit record highs  CNBC
2. The latest on the coronavirus pandemic: Live updates  CNN
3. Fauci says small gatherings driving new Covid outbreaks, worries about Thanksgiving  NBC News
4. Watch live: Dr. Anthony Fauci discusses coronavirus developments with the JAMA Network  CNBC
5. Here's a timeline of President Donald Trump's and Dr. Anthony Fauci's relationship  USA TODAY
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Nebraska-Wisconsin football game canceled because of COVID cases on Badger roster - Omaha World-Herald

1. Nebraska-Wisconsin football game canceled because of COVID cases on Badger roster  Omaha World-Herald
2. Wisconsin cancels football game vs. Nebraska after outbreak of COVID-19 cases  ESPN
3. Wisconsin-Nebraska football game canceled after positive coronavirus tests  WISN Milwaukee
4. Wisconsin pauses team activities for seven days, cancels game against Nebraska  Channel3000.com - WISC-TV3
5. College football game featuring Top 10 team canceled after head coach tests positive for COVID  Saturday Down South
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October 28, 2020 at 02:04PM Marisa Peyre: "Emerging diseases must be nipped in the bud right away"

How can we reduce the risks of diseases spreading from wildlife to humans? This is question addressed in a white paper and policy brief produced within the framework of the Sustainable Wildlife Management (SWM) programme and presented at the 2020 Global Landscapes Forum. Interview with Marisa Peyre, an epidemiologist with CIRAD specializing in animal and zoonotic disease surveillance, who was heavily involved in drafting these documents.

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Huskers, Badgers game canceled after Wisconsin players test positive for COVID-19 - KETV Omaha

1. Huskers, Badgers game canceled after Wisconsin players test positive for COVID-19  KETV Omaha
2. Nebraska continuing preparations for UW as report suggests Badgers may be unable to play due to COVID-19  Lincoln Journal Star
3. Wisconsin pauses team activities for seven days, cancels game against Nebraska  Channel3000.com - WISC-TV3
4. Wisconsin cancels football game vs. Nebraska after outbreak of COVID-19 cases  ESPN
5. Will the Wisconsin-Nebraska football game be played Saturday? Here’s what the Big Ten COVID-19 protocols say  Madison.com
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October 27, 2020 at 02:05PM The FAIR project is banking on agroecology to boost the resilience of producers in the Sahel

Agroecological intensification provides farmers with a decent income and local populations with healthy food, while conserving natural resources. Smallholders in three Sahel countries will be using these new methods to improve their living conditions and make their farms more resilient. The FAIR project will be supporting them in this undertaking. The project is coordinated by CIRAD and co-funded by AFD and the European Union, under the DeSIRA programme.

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France Emerges as Covid-19 Epicenter as Cases Surge Across Europe - The Wall Street Journal

1. France Emerges as Covid-19 Epicenter as Cases Surge Across Europe  The Wall Street Journal
2. Europe enacts new curbs as COVID surges in absence of vaccine  Yahoo News
3. WHO: Controlling COVID-19 needs personal sacrifice, tough restrictions - Business Insider  Business Insider
4. WHO says getting the worsening Covid outbreak under control may require 'sacrifice for many, many people'  CNBC
5. Europe, U.S. watch cases surge, debate new COVID-19 restrictions  FOX 4 Dallas
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Michigan Gov. Gretchen Whitmer announces COVID-19 grants for teachers, support staff - FOX 2 Detroit

1. Michigan Gov. Gretchen Whitmer announces COVID-19 grants for teachers, support staff  FOX 2 Detroit
2. Bomb materials found during investigation into alleged Whitmer kidnapping plot: report  Fox News
3. Northern Michigan county board considers resolution supporting Gov. Whitmer impeachment  MLive.com
4. 30 new COVID-19 outbreaks reported at Michigan schools and universities  Fox17
5. Trump lashes out at Whitmer as crowd reprises 'lock her up' chant | TheHill  The Hill
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October 26, 2020 at 04:03PM Treating and Preventing Head Lice

Head lice. Learn how to check for them, how to treat them, and how to avoid having them in your home.

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October 27, 2020 at 09:55PM Immunogenicity of Gene Therapy Products

Ronit Mazor's research project "Immunogenicity of Gene Therapy Products".

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October 27, 2020 at 08:25PM Biologics Guidances

This page displays links to Biologics Guidance documents.

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October 27, 2020 at 07:57PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020

This is the list of guidance topics CBER is considering for development during Calendar Year 2020.

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October 27, 2020 at 07:37PM VAXELIS

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3 dose series in children 6 weeks through 4 years of age (prior t

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October 27, 2020 at 02:05PM Le projet FAIR mise sur l’agroécologie pour accroître la résilience des producteurs sahéliens

L’intensification agroécologique permet de rémunérer décemment les agriculteurs, nourrir sainement les populations, tout en protégeant les ressources naturelles. Les petits producteurs de trois pays sahéliens pourront miser sur l’adoption de ces nouvelles méthodes pour améliorer leurs conditions de vie et la résilience de leur exploitation. Le projet FAIR les accompagnera vers cet objectif. Coordonné par le Cirad, il est co-financé par l’AFD et l’Union européenne dans le cadre du programme DeSIRA.

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October 27, 2020 at 01:30PM FDA Insight: Get Your Flu Vaccine

On this week's episode, Dr. Shah brings Dr. Peter Marks back to the show to discuss the importance of getting the flu vaccine. For more information about the flu vaccine, visit: https://www.fda.gov/flu

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Maine official alerted to potential COVID exposure after Pence visit - Press Herald

1. Maine official alerted to potential COVID exposure after Pence visit  Press Herald
2. Trump Encourages Poll Watching In Pennsylvania: 'We're Watching You Gov. Wolf' | NBC News NOW  NBC News
3. Vice President Mike Pence appeals to Iron Rangers with focus on jobs, economy  Minneapolis Star Tribune
4. White House signals defeat in pandemic as coronavirus outbreak roils Pence’s office  The Washington Post
5. As Covid threat surges, Trump and Pence try 2 acts to save GOP ticket  POLITICO
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Olivia Troye Says White House 'Never Cared' About COVID, Pence's Chief of Staff Joked About Masks - Newsweek

1. Olivia Troye Says White House 'Never Cared' About COVID, Pence's Chief of Staff Joked About Masks  Newsweek
2. Trump Encourages Poll Watching In Pennsylvania: 'We're Watching You Gov. Wolf' | NBC News NOW  NBC News
3. Vice President Mike Pence appeals to Iron Rangers with focus on jobs, economy  Minneapolis Star Tribune
4. White House signals defeat in pandemic as coronavirus outbreak roils Pence’s office  The Washington Post
5. Mike Pence Campaign Rally Violates Minnesota COVID Rules as Experts Urge Him to Quarantine  Newsweek
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October 26, 2020 at 09:57PM Vaccines Research

List of Vaccines Research.

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October 26, 2020 at 09:51PM Gastrointestinal Viruses: Understanding Diversity and Immune Responses to Inform Vaccine Design

Gabriel Parra's research project "Gastrointestinal Viruses: Understanding Diversity and Immune Responses to Inform Vaccine Design".

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October 26, 2020 at 08:28PM VAQTA

For active immunization against disease caused by hepatitis A virus in persons 12 months of age and older.

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Mike Pence 'Proud' of Trump over COVID as White House Gives up Containing Virus - Newsweek

1. Mike Pence 'Proud' of Trump over COVID as White House Gives up Containing Virus  Newsweek
2. White House signals defeat in pandemic as coronavirus outbreak roils Pence’s office  The Washington Post
3. POLITICO Playbook: The first Obama book excerpt - POLITICO  Politico
4. Column: Trump fearlessly surrenders to the coronavirus as cases surge nationwide: ‘It’s going to be over,’ he lied  Chicago Tribune
5. We finally know the Trump administration’s pandemic strategy: Surrender  The Washington Post
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October 21, 2020 at 03:45PM Combining agricultural emissions reduction policies to balance biodiversity conservation and food security

Sharing efforts between biofuel production, the transition to reduced-meat diets and the reforestation of pastures would be a far better option for tomorrow’s agriculture than focusing on just one of these strategies. This mix would simultaneously address the goals of food security, biodiversity conservation and emissions reductions, according to a study published by CIRAD and its partners in Environmental Research Letters .

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White House signals defeat in pandemic as coronavirus outbreak roils Pence’s office - The Washington Post

White House signals defeat in pandemic as coronavirus outbreak roils Pence’s office  The Washington PostView Full Coverage on Google News

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Infection of Pence Aides Raises New Questions About Trump’s Virus Response - The New York Times

1. Infection of Pence Aides Raises New Questions About Trump’s Virus Response  The New York Times
2. White House chief of staff: 'We are not going to control the pandemic'  CNN
3. Pence hits Biden for 'undermining' law enforcement, tells Levin 'all my heroes wear uniforms'  Fox News
4. White House signals defeat in pandemic as coronavirus outbreak roils Pence’s office  The Washington Post
5. The Barrett Vote: There’s Not a Good Reason for Mike Pence to Preside Over It  National Review
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Australia's coronavirus epicenter records no new cases as the US and Western Europe struggle to contain the pandemic - CNN

1. Australia's coronavirus epicenter records no new cases as the US and Western Europe struggle to contain the pandemic  CNN
2. Daniel Andrews says 'now is the time to open up' after Victoria records no Covid cases  Guardian News
3. Australian city Melbourne to exit one of world's longest lockdowns  Axios
4. Australia's coronavirus epicentre to ease curbs after no new cases  Yahoo News
5. Asia Today: Melbourne holds off on easing amid new outbreak  Washington Post
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Spain, Italy impose tougher lockdown measures as COVID-19 cases surge - New York Post

1. Spain, Italy impose tougher lockdown measures as COVID-19 cases surge  New York Post
2. Spain orders nationwide curfew to stem coronavirus outbreak  Los Angeles Times
3. Spain orders nationwide curfew to stem worsening outbreak  Associated Press
4. Italy imposes harshest coronavirus restrictions since spring lockdown as second wave sweeps Europe  The Washington Post
5. Italy, Spain adopt curfews, new rules to blunt COVID as cases spike worldwide  MassLive.com
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October 26, 2020 at 09:48AM What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

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October 23, 2020 at 04:38PM 4th International Conference on Global Food Security

Organized with the support of CIRAD.

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October 26, 2020 at 02:07AM Prueba de detección del cáncer de seno: La termografía no sustituye la mamografía

A pesar de muchas afirmaciones públicas sobre el termograma, esta nunca debe usarse como reemplazo de una mamografía para la detección o el diagnóstico del cáncer de seno.

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October 26, 2020 at 01:27AM Breast Cancer Screening: Thermogram No Substitute for Mammogram

Thermography should not be used in place of mammography, which is still the most effective tool for detecting breast cancer.

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October 25, 2020 at 11:52PM Mammography: What You Need to Know

Mammograms are still the best tool for breast cancer screening. As we observe Breast Cancer Awareness Month this October, learn how FDA certifies facilities that perform mammography, and clears and approves mammography devices, to help keep you safe.

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Spain orders second nationwide state of emergency, night curfew amid coronavirus spike - Fox News

1. Spain orders second nationwide state of emergency, night curfew amid coronavirus spike  Fox News
2. Covid: Spain imposes national night-time curfew to curb infections  BBC News
3. Spain orders nationwide curfew to stem worsening outbreak  Associated Press
4. Spain announces new state of emergency as COVID infections soar  Yahoo News
5. Spain declares new state of emergency as COVID-19 cases surge  Axios
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Spain orders nationwide curfew to stem worsening outbreak - Associated Press

Spain orders nationwide curfew to stem worsening outbreak  Associated PressView Full Coverage on Google News

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North Dakota's active COVID cases, hospitalizations reach new highs - Bismarck Tribune

1. North Dakota's active COVID cases, hospitalizations reach new highs  Bismarck Tribune
2. Gov. Burgum announces new reporting methods for COVID-19 deaths, issues “Thanksgiving Challenge”  KX NEWS
3. Burgum says North Dakota can weather pandemic as state continues to have worst outbreak in US  Grand Forks Herald
4. NDDoH official says Private Gatherings have been biggest spreader of COVID-19  KVLY
5. 30,000 rapid COVID-19 tests have arrived in North Dakota  KX NEWS
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NDDoH official says Private Gatherings have been biggest spreader of COVID-19 - KVLY

1. NDDoH official says Private Gatherings have been biggest spreader of COVID-19  KVLY
2. North Dakota's active COVID cases, hospitalizations reach new highs  Bismarck Tribune
3. North Dakota reaches record high in active cases; state continues to have worst outbreak in the US  Grand Forks Herald
4. 3:30PM Live News Conference: Gov. Doug Burgum will provide an update on the COVID-19 pandemic in North Dakota  KVLY
5. 9 deaths, 886 new COVID-19 cases in ND; active cases statewide are 6,363  KX NEWS
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October 23, 2020 at 11:23PM Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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October 23, 2020 at 08:28PM Alimentos y Bebidas

Información para el consumidor sobre la seguridad de los alimentos.

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October 23, 2020 at 08:24PM Devices Guidances

This page lists Medical Device Guidance documents.

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October 23, 2020 at 05:40PM Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

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October 23, 2020 at 04:38PM 4e Conférence internationale sur la sécurité alimentaire mondiale

Organisée avec le soutien du Cirad.

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October 23, 2020 at 04:34PM Global Landscapes forum

Avec la participation du Cirad.

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October 23, 2020 at 03:34PM Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency

CDER is committed to supporting the development of novel drugs, and the potential repurposing of existing therapies, to address the Coronavirus Disease 2019 (COVID-19) public health emergency.

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October 23, 2020 at 03:31PM Developing and Manufacturing Drugs Including Biologics

This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a comprehensive list of all applicable statutory and regulatory requirements.

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October 23, 2020 at 03:29PM Development and Licensure of Vaccines to Prevent COVID-19

This is the Guidance for Industry, Development and Licensure of Vaccines to Prevent COVID-19, CBER, Biologics

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October 23, 2020 at 03:00PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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October 23, 2020 at 02:41PM Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy
Guidance for Industry




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October 23, 2020 at 01:38PM Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.

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October 23, 2020 at 01:40PM Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

There are currently no FDA-approved drugs, including vaccines, to treat or prevent COVID-19. Products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness; they might be dangerous to you and your family.

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October 23, 2020 at 01:38PM Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.

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October 22, 2020 at 05:06PM Help Stop the Spread of Coronavirus and Protect Your Family

We can each help slow the spread of coronavirus disease and protect ourselves, our families and our communities. Wash your hands often with soap and water; cover your mouth and nose with a cloth face covering or non-surgical mask when around others; 3) avoid crowds and practice social distancing.

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October 23, 2020 at 01:14PM Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses

Enjoy a happy and safe Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention.

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October 22, 2020 at 11:23PM Donate COVID-19 Plasma

If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. Because you fought the infection, your plasma now contains COVID-19 antibodies.

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October 22, 2020 at 09:36PM Manufacturing Site Change Supplements: Content and Submission

This guidance explains what constitutes a manufacturing site change and when you should submit a PMA supplement for a site change; what documentation you should submit in a site change supplement; and the general factors FDA intends to consider when determining whether conduct an inspection.

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October 22, 2020 at 08:25PM Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

Guidance for Industry - Procedural

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October 22, 2020 at 06:49PM Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components

We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components.

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October 21, 2020 at 03:45PM Combiner les politiques agricoles de réduction des émissions de gaz à effet de serre pour concilier préservation de la biodiversité et sécurité alimentaire

Répartir les efforts entre la production de biocarburants, une transition vers des régimes alimentaires moins carnés et la reforestation de pâture serait une bien meilleure option pour l’agriculture de demain que de miser uniquement sur une seule de ces stratégies. Cette combinaison permettrait d’allier à la fois des objectifs de sécurité alimentaire, de préservation de la biodiversité et de réduction des émissions de gaz à effet de serres, selon une étude publiée par le Cirad et ses partenaires dans Environmental Research Letters .

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October 20, 2020 at 09:20PM Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions

This guidance document is intended to help sponsors and applicants understand and comply with the new requirements of 21 CFR parts 807, 812 and 814.

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October 20, 2020 at 09:19PM Medical Device User Fee Small Business Qualification and Certification

This guidance describes the process for how a business may request qualification and certification as a small business.

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October 20, 2020 at 09:17PM Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics

This guidance document describes factors FDA uses to evaluate the benefit-risk profile of a device in comparison to a predicate device in a 510(k).

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October 20, 2020 at 09:16PM User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

Identifes types of PMAs and BLAs subject to device user fees; exceptions to user fees; the actions that may result in refunds of user fees that have been paid.

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October 20, 2020 at 09:13PM The Least Burdensome Provisions: Concept and Principles

This guidance describes FDA's least burdensome approach to device regulation to eliminate unnecessary burdens, while maintaining the statutory requirements.

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October 20, 2020 at 09:12PM Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

This guidance document describes the factors FDA considers when making benefit-risk determinations during premarket review for certain medical devices.

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October 20, 2020 at 09:07PM Acceptance Review for De Novo Classification Requests

Procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation meets a minimum threshold...

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October 20, 2020 at 08:40PM FDA Voices on Medical Products

FDA Voices on Medical Products

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October 20, 2020 at 08:03PM Consejos de seguridad para el Día de las Brujas: disfraces, dulces, lentes de colores

Se acerca la noche de brujas o Halloween, lea este artículo con consejos para tener un Halloween seguro.

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October 20, 2020 at 07:47PM Halloween Safety: Costumes, Candy, and Colored Contact Lenses

Enjoy a happy and safe Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention.

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October 20, 2020 at 07:07PM The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines

This week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.

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October 20, 2020 at 06:32PM Cooperative Manufacturing Arrangements for Licensed Biologics

This is the Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics.

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October 20, 2020 at 04:44PM Tobacco Products

Tobacco comes in many forms, from cigars and cigarettes to smokeless tobacco and dissolvable nicotine products. FDA works to reduce the use of these products, and the harm that they cause. To learn more read these Consumer Updates.

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October 20, 2020 at 04:46PM FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

This guidance establishes procedures for submitting, reviewing and responding to 513(g) requests for information regarding the classification and the regulatory requirements that may be applicable to a particular device.

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October 20, 2020 at 04:43PM 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes

Provides guidance on the changes FDA believes may qualify for the 30-day notice and the changes that generally do not qualify.

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October 20, 2020 at 04:36PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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October 20, 2020 at 03:02PM Advisory Committees Give FDA Critical Advice and the Public a Voice

Not familiar with FDA’s advisory committees? These committees provide independent, expert advice to the FDA on a range of complex scientific, technical and policy issues related to the development and evaluation of FDA-regulated products.

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October 20, 2020 at 03:02PM Advisory Committees Give FDA Critical Advice and the Public a Voice

Not familiar with FDA’s advisory committees? These committees provide independent, expert advice to the FDA on a range of complex scientific, technical and policy issues related to the development and evaluation of FDA-regulated products.

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October 20, 2020 at 02:53PM Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry

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October 20, 2020 at 02:30PM FDA Insight: Advisory Committee on COVID-19 Vaccines

Dr. Peter Marks, FDA's Director of the Center for Biologics Evaluation and Research, returns for his third episode to provide an update on COVID-19 vaccines and to discuss the upcoming Vaccines and Related Biological Products Advisory Committee meeting.

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COVID cases force district to close North Fulton high school for 3 days - Atlanta Journal Constitution

1. COVID cases force district to close North Fulton high school for 3 days  Atlanta Journal Constitution
2. Coronavirus outbreak tied to high school party dashes Oregon district’s plans for in-person instruction  OregonLive
3. Back to school: Many large districts are opening their doors again  The Washington Post
4. TPS To Keep Middle, Jr. High, High School Students In Distance Learning Until January  News On 6
5. Coronavirus: 73 new cases this weekend in Onondaga County; 5 schools start week with remote learning  syracuse.com
6. View Full Coverage on Google News

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COVID-19 outbreak infects every resident — and kills 10 — at Kansas nursing home - New York Post

1. COVID-19 outbreak infects every resident — and kills 10 — at Kansas nursing home  New York Post
2. 10 residents dead amid virus outbreak at Kansas nursing home  WDAF FOX4 Kansas City
3. All 62 residents in Norton County nursing home test positive for COVID-19, of which 10 have passed away  KSN-TV
4. COVID-19 kills 10 at NW Kansas nursing facility  KWCH
5. All 62 Residents of Kansas Nursing Home Get COVID—and 10 Die  The Daily Beast
6. View Full Coverage on Google News

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Rising Covid case totals could hinder plans for New Jersey's economic reopening - POLITICO

1. Rising Covid case totals could hinder plans for New Jersey's economic reopening  POLITICO
2. Gov. Murphys New Coronavirus Advice To NJ: Dont Travel  Ocean City, NJ Patch
3. Private indoor gatherings cited among top causes of N.J.'s recent COVID-19 outbreaks, health official says  NJ.com
4. The second coronavirus wave is here in NJ. Here's why it's different from last time.  NorthJersey.com
5. New Jersey COVID-19 Cases Have Doubled Since Last Month | NBC10 Philadelphia  NBC10 Philadelphia
6. View Full Coverage on Google News

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Titans may be fined, but no suspensions or lost draft picks for COVID-19 violations - NBC Sports - NFL

1. Titans may be fined, but no suspensions or lost draft picks for COVID-19 violations  NBC Sports - NFL
2. Source -- Tennessee Titans face potential fine as NFL concludes COVID review  ESPN
3. Titans informed review of outbreak has concluded; fine possible  NFL.com
4. AP source: No talk of individual punishment for Titans  Taiwan News
5. Report: Titans face fine, avoid harsher penalties after NFL investigation into COVID-19 outbreak  Yahoo Sports
6. View Full Coverage on Google News

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October 19, 2020 at 09:31PM Resources Related to Regenerative Medicine Therapies

Information on FDA’s Framework for the Regulation of Regenerative Medicine Products


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October 19, 2020 at 04:45PM Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent and treat Ebola will show efficacy

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October 19, 2020 at 04:05PM FDA’s Technology Modernization Action Plan Accelerates the Path to Enhancing and Promoting “People First” Public Health

FDA’s TMAP is the blueprint for modernizing our IT systems. TMAP enables technology and data to innovate our regulatory mission and critical functions and empower our workforce to be as nimble and up-to-date as the products we regulate.

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October 16, 2020 at 10:41PM Procleix Ultrio Assay

Product approval information is intended for:

• Use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
• Use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors.
• Use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma.
• Used in conjunction with licensed tests for detecting antibodies to HIV-1, HCV, and hepatitis B core antigen (anti-HBc), and with licensed tests for hepatitis B surface antigen (HBsAg).

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October 16, 2020 at 10:38PM Procleix Ultrio Plus Assays

Product approval information for:
•Use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
•Use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors.
•Use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma.

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October 16, 2020 at 07:12PM Procleix Ultrio Elite Assay

•Intended to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from individual human donors, including donors of whole blood, blood compo

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October 16, 2020 at 05:56PM Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

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October 15, 2020 at 06:53PM Gender and foodways under urban lifestyles

The latest "Eating in the Cities" symposium was held on 30 September and 1 October 2020. This third, virtual edition shone a light on the changes in gender relations as a result of urbanization on three continents. It was organized by CIRAD and the UNESCO Chair in World Food Systems, and brought together 480 participants from more than 40 countries. Extracts.

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October 15, 2020 at 06:53PM Genre et alimentation à l’épreuve de la vie urbaine

Le dernier symposium « Manger en ville » s’est tenu le 30 septembre et le 1er octobre 2020. Cette 3e édition a donné à voir des changements dans les rapports de genre liés à l’urbanisation sur trois continents. Organisé par le Cirad et la Chaire Unesco Alimentations du Monde, l’évènement a virtuellement réuni 480 participants de plus de 40 pays. Morceaux choisis.

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October 15, 2020 at 02:08PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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October 15, 2020 at 02:01PM Testing for Biotin Interference in In Vitro Diagnostic Devices

Testing for Biotin Interference in In Vitro Diagnostic Devices, Guidance for Industry, Final, CBER, Biologics

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Patriots rally around Belichick amid COVID-19 outbreak - Fox News

1. Patriots rally around Belichick amid COVID-19 outbreak  Fox News
2. New England Patriots' Cam Newton to rejoin team Thursday after COVID-19  ESPN
3. Newton on track to start Sunday vs. Broncos; Ryan trade rumours swirling in Atlanta  TSN
4. Rex Burkhead praises Bill Belichick's handling of COVID-19  RADIO.COM
5. 'A student of everything' - What a 26-year-old Bill Belichick learned as a Broncos assistant  ESPN
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Gators pause football activities after 19 COVID-19 cases - Orlando Sentinel

1. Gators pause football activities after 19 COVID-19 cases  Orlando Sentinel
2. Florida Gators stop football activities after coronavirus outbreak  ESPN
3. Texas A&M AD: ‘No impact’ so far after Florida's positive COVID tests  Houston Chronicle
4. Florida halts meetings, practices amid 19 new COVID cases  WKMG News 6 & ClickOrlando
5. Gators halt football activities as COVID-19 cases rise within program  News4JAX
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October 13, 2020 at 10:44PM Dr. Hahn's Remarks to the Reagan Udall Foundation Annual Meeting - 10/13/2020

Remarks by Stephen Hahn, MD, Commissioner of Food and Drugs, Reagan Udall Foundation Annual Meeting, Oct. 13, 2020, Washington, DC

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Monmouth University 'super-spreader event' led to 125 Covid cases on New Jersey campus - NBC News

1. Monmouth University 'super-spreader event' led to 125 Covid cases on New Jersey campus  NBC News
2. Monmouth University COVID-19 outbreak mostly from 'super-spreader' event  New York Post
3. Off-campus "super-spreader" event linked to 125 virus cases at Monmouth University  CBS News
4. 'Super-spreader event' linked to about 125 COVID-19 cases at Monmouth University  ABC News
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October 13, 2020 at 07:26PM Do Not Use: Black Salve is Dangerous and Called by Many Names

Salves that contain corrosive ingredients, including “black salve” and a number of other names, are dangerous and can be life-threatening. Here’s why.

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October 12, 2020 at 05:05PM Agroecology is at the heart of the international debate on the transformation of agrifood systems

The High-Level Special Event on Global Governance of Food Security and Nutrition, organized by the Committee on World Food Security (CFS) from 13 to 15 October, begins today. In a new book, a group of experts has called for a faster transformation of our food systems. Three economists from CIRAD contributed to the book, which stresses the importance of an agroecological transition of current production systems.

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Dr. Anthony Fauci says he won't walk away from 'this outbreak no matter who's the president' - CNBC

1. Dr. Anthony Fauci says he won't walk away from 'this outbreak no matter who's the president'  CNBC
2. Dr. Fauci reacts to Trump ad: It's clear I'm not a political person  CNN
3. The Trump campaign is also using the top US general in a political ad, evidently without his consent  The Week
4. Dr. Fauci says U.S. faces 'a whole lot of trouble' as coronavirus cases rise heading into winter  CNBC
5. Fauci says Trump campaign should take down ad featuring him  CNN
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