March 31, 2021 at 11:28PM TRG Rapid Inquiry Program (TRIP)

As a result of the July 2020 update the FDA's guidance document, "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use", FDA extended the TRIP program. It ended on March 31, 2021.

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March 31, 2021 at 08:07PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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March 30, 2021 at 10:24PM Database of Pharmacogenomic Information in Ethnic Minority Populations (dbPGxEMP)

Differences in genes can make someone more or less likely to benefit from a drug, suffer side effects, or require a dose that is different from other people. Such pharmacogenomic (PGx) information can be used to improve the medical decision-making process.

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March 30, 2021 at 07:46PM Transfusion/Donation Fatalities

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

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Global leaders call for a pandemic treaty, saying another outbreak is 'only a matter of time' - CNBC

1. Global leaders call for a pandemic treaty, saying another outbreak is 'only a matter of time'  CNBC
2. Global treaty needed to protect states from pandemics, say world leaders  The Guardian
3. 23 world leaders back treaty proposal on health emergencies like pandemic | TheHill  The Hill
4. World leaders call for international pandemic treaty  Associated Press
5. The Latest: Leaders call for pandemic preparedness treaty  WBOY.com
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Dr. Joneigh Khaldun voices concern as COVID cases in Michigan increase - WDIV ClickOnDetroit

1. Dr. Joneigh Khaldun voices concern as COVID cases in Michigan increase  WDIV ClickOnDetroit
2. Michigan reports 8,200 coronavirus cases, dozens more school outbreaks  WOODTV.com
3. Covid cases spiking again in Michigan, but Gov. Whitmer making no move to impose new restrictions  NBC News
4. Michigan coronavirus cases up to 660,771; Death toll now at 16,034  WDIV ClickOnDetroit
5. Jackson ranked as number one for worst COVID-19 outbreak in the nation, according to NY Times  WILX-TV
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Michigan reports 8,200 coronavirus cases, dozens more school outbreaks - WOODTV.com

1. Michigan reports 8,200 coronavirus cases, dozens more school outbreaks  WOODTV.com
2. Michigan coronavirus cases up to 660,771; Death toll now at 16,034  WDIV ClickOnDetroit
3. Michigan reports 8,202 new COVID-19 cases, 8 deaths over 2-day period  Detroit Free Press
4. Michigan's COVID-19 hospitalizations rising at faster rate than in fall  The Detroit News
5. Michigan virus surge, vaccinations up: Where things stand this week  WDIV ClickOnDetroit
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U.S. Officials Air Concerns About WHO's Covid Origin Report - Bloomberg

1. U.S. Officials Air Concerns About WHO's Covid Origin Report  Bloomberg
2. What happened in Wuhan? Why questions still linger on the origin of the coronavirus - 60 Minutes  CBS News
3. Joint report from China, WHO says animals were likely source of COVID-19  New York Post
4. WHO’s inquiry into COVID-19 outbreak ‘highly chaperoned,’ says ex-NSC official  Fox News
5. Former NSC official raises concerns of interference in pandemic origins probe  Yahoo News
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Omaha daycare is closing after UK COVID-19 variant outbreak - 1011now

Omaha daycare is closing after UK COVID-19 variant outbreak  1011nowView Full Coverage on Google News

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Blinken suggests US won't take punitive action against China over coronavirus outbreak - CNN

1. Blinken suggests US won't take punitive action against China over coronavirus outbreak  CNN
2. Blinken dodges question on punishing China for COVID-19 pandemic  New York Post
3. Blinken suggests US won't take punitive action on China over COVID-19 | TheHill  The Hill
4. Dana Bash pushes Secy. of State Blinken on repercussions for China's management of Covid-19  CNN
5. Blinken punts on punishing China for coronavirus outbreak  POLITICO
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Virus Outbreak: News and Analysis From March 28 - Bloomberg

Virus Outbreak: News and Analysis From March 28  Bloomberg

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This country only has about 500 doctors for 9 million people. Now it's dealing with a Covid outbreak - CNN

This country only has about 500 doctors for 9 million people. Now it's dealing with a Covid outbreak  CNN View Full Coverage on Google News

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Virus Outbreak: News and Analysis From March 28 - Bloomberg

Virus Outbreak: News and Analysis From March 28  Bloomberg

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A Collapse Foretold: How Brazil’s Covid-19 Outbreak Overwhelmed Hospitals - The New York Times

1. A Collapse Foretold: How Brazil’s Covid-19 Outbreak Overwhelmed Hospitals  The New York Times
2. Signs of collapse across Brazil as Covid spirals out of control. Bolsonaro seems to have little response  CNN
3. Covid-19 Variant Rages in Brazil, Posing Global Risk  The Wall Street Journal
4. Younger Brazilians Are Dying From Covid in an Alarming New Shift  Bloomberg
5. As daily deaths near 4,000, worst may lie ahead for Brazil  Associated Press
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Mid-South recovers from deadly tornadoes as region braces for severe weather, more storms - Fox News

1. Mid-South recovers from deadly tornadoes as region braces for severe weather, more storms  Fox News
2. Long Clean Up Begins After Tornadoes Carve Deadly Path Of Destruction In Alabama, Georgia | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
3. Severe Weather in Alabama Flattens Homes, Tears Off Roofs  Bloomberg Quicktake: Now
4. Severe thunderstorms possible in D.C. area Sunday for first time this year  The Washington Post
5. At least 5 killed in tornado outbreaks in South l GMA  Good Morning America
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March 27, 2021 at 02:43PM FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma

The FDA approved Abecma, the first cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.

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March 27, 2021 at 02:05PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

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Catastrophic damage after tornado strikes overnight in Georgia - NBC News

1. Catastrophic damage after tornado strikes overnight in Georgia  NBC News
2. Dispatch recorded 911 calls on paper during storm when system went down in Coweta County  11Alive
3. Tornadoes roll across 5 southern states causing at least 5 deaths and heavy destruction  CNN
4. ‘You could hear it coming’: 1 dead as ‘catastrophic’ tornado hits south of Atlanta  Atlanta Journal Constitution
5. EF-4 destroys much of Newnan during severe weather outbreak  CBS46 Atlanta
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March 25, 2021 at 08:53PM Multilingual COVID-19 Resources

The U.S. Centers for Disease Control and Prevention (CDC), and international and U.S. Government partners including FDA, are addressing an outbreak of coronavirus disease 2019 (COVID-19).

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March 25, 2021 at 06:29PM Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Class II Special Controls Guidance Document for Industry and FDA Staff

Developed as a special control to support the classification of the West Nile virus (WNV) serological reagents into class II (special controls).

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March 24, 2021 at 08:06PM Tissue Notices, Proposed and Final Rules

List of Tissue Notices, Proposed and Final Rules

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March 24, 2021 at 11:24PM SHINGRIX

This is the main page for the CBER SHINGRIX.

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March 24, 2021 at 06:03PM Learn More About COVID-19 Vaccines From the FDA

Get answers to your questions about the standards for safety and effectiveness to support an emergency use authorization of COVID-19 vaccines.

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March 23, 2021 at 07:28PM 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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March 22, 2021 at 03:17PM Help Stop the Spread of Coronavirus and Protect Your Family

We can each take simple steps to slow the spread of COVID-19 and protect ourselves, our families and our communities. Get a COVID-19 vaccine. Wash your hands often. Cover your mouth and nose with a mask when around others. Avoid crowds and practice social distancing.

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March 22, 2021 at 01:51PM Contacts in the Center for Biologics Evaluation & Research (CBER)

List of contact information in the Center for Biologics Evaluation & Research (CBER)

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Donald Trump's Mar-a-Lago resort partially closed by Covid-19 outbreak - The Guardian

1. Donald Trump's Mar-a-Lago resort partially closed by Covid-19 outbreak  The Guardian
2. Mar-a-Lago partially closed due to Covid outbreak  CNN
3. Trump's Mar-a-Lago partially closed due to COVID outbreak  CBS Evening News
4. Trump's Mar-a-Lago partially closed due to Covid outbreak  POLITICO
5. Trump’s Mar-a-Lago Club partially closed after staff infected with coronavirus  The Washington Post
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Trump's Mar-a-Lago partially closed due to COVID outbreak - Associated Press

Trump's Mar-a-Lago partially closed due to COVID outbreak  Associated PressView Full Coverage on Google News

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Trump's Mar-a-Lago partially closed due to COVID outbreak - Associated Press

1. Trump's Mar-a-Lago partially closed due to COVID outbreak  Associated Press
2. Mar-a-Lago Closed Due To COVID Outbreak  CBS Miami
3. Mar-a-Lago partially closed due to Covid outbreak  CNN
4. Mar-a-Lago partially closes after COVID-19 outbreak  WPTV News - FL Palm Beaches and Treasure Coast
5. COVID-19 outbreak at Trump's Mar-a-Lago club leads to partial closure, per report  Business Insider
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March 19, 2021 at 07:08PM Coronavirus (COVID-19) Update: March 19, 2021

Coronavirus (COVID-19) Update: March 19, 2021

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Here's what experts say is needed for US to return to normal. But these barriers stand in the way - CNN

1. Here's what experts say is needed for US to return to normal. But these barriers stand in the way  CNN
2. U.S. could see new COVID-19 spike after recent dip  Deseret News
3. Dr. Anthony Fauci on COVID-19 variants, latest on vaccines, concerns as spring approaches  CBS This Morning
4. Dr. Fauci on vaccines in Alabama and fall football  WBRC
5. Fauci Says We're Still in Middle of a Serious Covid Outbreak  Bloomberg
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CDC relaxes distance requirements in schools from 6 to 3 feet - NBC News

1. CDC relaxes distance requirements in schools from 6 to 3 feet  NBC News
2. Updated CDC guidance says 3 feet of physical distancing is safe in schools  CNN
3. CDC shortens Covid social distancing guidelines for kids in school to 3 feet with masks  CNBC
4. COVID science, CDC hints point to full-time, in-person school  Los Angeles Times
5. CDC to change school social distancing guidelines as metro Detroit schools deal with outbreaks  WXYZ-TV Detroit | Channel 7
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March 15, 2021 at 06:49PM Bar Code Label Requirements

Blood and blood components must be labeled with specific machine-readable bar code information by April 26th, 2006. The purpose of the bar coding rule is to reduce transfusion errors and increase patient safety.

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March 17, 2021 at 10:24PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 130,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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March 18, 2021 at 07:00PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

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'Particularly Dangerous Situation': Tornado Outbreak Underway in Mississippi, Alabama, Deep South | The Weather Channel - Articles from The Weather Channel | weather.com - The Weather Channel

1. 'Particularly Dangerous Situation': Tornado Outbreak Underway in Mississippi, Alabama, Deep South | The Weather Channel - Articles from The Weather Channel | weather.com  The Weather Channel
2. Southeast braced for a significant tornado outbreak as storms move into the area  CNN
3. Central North Carolina prepares for first Moderate Risk day in two years  CBS17.com
4. Millions across Southeast US bracing for potential tornadoes  Times of India
5. Threat increases: Vicksburg placed under high risk for 'long-track tornadoes' - The Vicksburg Post  Vicksburg Post
6. View Full Coverage on Google News

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March 17, 2021 at 05:11PM Improvement of Biological Product Quality by Application of New Technologies to Characterize of Vaccines and Blood Products: NMR Spectroscopy and Light Scattering

A description of Daron Freedberg's research program and related publications.

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March 17, 2021 at 02:36PM 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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March 16, 2021 at 10:20PM Influenza neuraminidase antigenicity and efficacy in vaccines

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

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March 16, 2021 at 10:01PM FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus

FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus

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March 16, 2021 at 09:36PM FY 2019 Report from the Director

Fiscal Year 2019 was an exciting time at CBER, as we continued to conduct important mission-oriented research and approved important new products that protect and improve public health. These included a novel gene therapy, vaccines, treatments for immune deficiencies, and tests for protection of the

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March 16, 2021 at 09:14PM FY 2018 Report from the Director

FY 2018 Report from the Director, Dr. Peter Marks

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March 16, 2021 at 08:53PM Coronavirus (COVID-19) Update: March 16, 2021

Coronavirus (COVID-19) Update: March 16, 2021

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March 16, 2021 at 06:11PM Animal Rule Information

Links to information about the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible

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Georgians scramble for vaccine slots on day 1 of expanded eligibility - Atlanta Journal Constitution

1. Georgians scramble for vaccine slots on day 1 of expanded eligibility  Atlanta Journal Constitution
2. US prison guards refusing vaccine despite COVID-19 outbreaks  The Associated Press
3. 2,247 doses of COVID-19 vaccine go to waste in Wisconsin  FOX 6 Milwaukee
4. Georgia's COVID-19 case curve as of March 14th  13WMAZ.com
5. Oklahoma City Mayor David Holt receives COVID-19 vaccine  KOCO 5 News
6. View Full Coverage on Google News

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US prison guards refusing vaccine despite COVID-19 outbreaks - The Associated Press

1. US prison guards refusing vaccine despite COVID-19 outbreaks  The Associated Press
2. Eligible Southeast Michigan residents can schedule a vaccine at Ford Field today  FOX 2 Detroit
3. 2,349 doses of COVID-19 vaccine go to waste in Wisconsin  FOX 6 Milwaukee
4. Mississippi Opens Covid Vaccine Eligibility to Everyone  The New York Times
5. Extent of COVID-19 vaccine waste remains largely unknown  Associated Press
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March 15, 2021 at 06:49PM Bar Code Label Requirements

Blood and blood components must be labeled with specific machine-readable bar code information by April 26th, 2006. The purpose of the bar coding rule is to reduce transfusion errors and increase patient safety.

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Duke University under a mandatory schoolwide quarantine amid frat party-linked coronavirus surge - The Washington Post

1. Duke University under a mandatory schoolwide quarantine amid frat party-linked coronavirus surge  The Washington Post
2. Duke University undergrads ordered to stay in place all week as Covid-19 cases spike  CNN
3. Duke undergrads ordered to stay in dorms for one week due to outbreak  Business Insider
4. Duke COVID: Strong reaction among Duke University students after fraternities activities lead to more COVID cases, lockdown  WTVD-TV
5. All Duke University undergrads must quarantine after recruitment parties  Fox News
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3 vaccinated Hawaii residents tested positive for COVID-19 - FOX31 Denver

1. 3 vaccinated Hawaii residents tested positive for COVID-19  FOX31 Denver
2. COVID-19 outbreak at Langley glass manufacturer  NEWS 1130
3. 44 employees test positive in COVID-19 outbreak at Langley glass factory  CBC.ca
4. B.C.’s oldest COVID-19 survivor to celebrate 105th birthday in Vernon  Vernon Morning Star
5. COVID-19 outbreak at Royal Columbian Hospital declared over by Fraser Health  CTV News Vancouver
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Duke announces week-long stay-at-home order for undergrads starting at midnight Saturday - WRAL.com

1. Duke announces week-long stay-at-home order for undergrads starting at midnight Saturday  WRAL.com
2. Duke University undergraduates to quarantine after recruitment parties | TheHill  The Hill
3. All Duke University undergrads must quarantine after COVID outbreak  New York Post
4. Duke puts temporary ‘stay-in-place’ restrictions on campus to stop spread of COVID  Raleigh News & Observer
5. The Latest: All Duke University undergrads must quarantine  The Associated Press
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Health officials detect first cases of Brazilian COVID-19 variant in Arizona - AZFamily

1. Health officials detect first cases of Brazilian COVID-19 variant in Arizona  AZFamily
2. One chart shows how well COVID-19 vaccines work against the 3 most worrisome coronavirus variants  Business Insider
3. First case of COVID-19 U.K. variant found in Spokane County  KHQ Right Now
4. Virus Outbreak: News and Analysis From March 13  Bloomberg
5. Japanese authorities discover a new coronavirus variant in traveler from Philippines  The Japan Times
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March 10, 2021 at 06:49PM Study of the regulation of blood coagulation by factors VIIa and IXa

A description of Mikhail Ovanesov's research program and related publications.

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Critics fume after Github removes exploit code for Exchange vulnerabilities - Ars Technica

1. Critics fume after Github removes exploit code for Exchange vulnerabilities  Ars Technica
2. Microsoft email hack: How does the attack work? What Microsoft is doing? English News  WION
3. As firms race to patch Microsoft Exchange flaw, security pros brace for ransomware outbreak  CyberScoop
4. There’s a vexing mystery surrounding the 0-day attacks on Exchange servers  Ars Technica
5. Ransom-seeking hackers are taking advantage of Microsoft flaw: expert  Reuters
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March 11, 2021 at 11:38PM Micro Typing Systems A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card

Manufacture of a "Monoclonal Rh Phenotype Card"

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March 11, 2021 at 11:16PM FDA Patient Engagement Opportunities

A description of some of the opportunities for patients, caregivers and advocates to engage with the FDA.

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March 11, 2021 at 10:31PM MTS Anti-IgG Card

Indicated For in vitro blood banking reagent

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March 11, 2021 at 02:53PM MTS A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card

Manufacture of a "Monoclonal Rh Phenotype Card"

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March 11, 2021 at 09:06PM Remarks by FDA Chief Scientist Denise Hinton to the Professional Services Council FedHealth Conference - 03/11/2021

Remarks by FDA Chief Scientist Denise Hinton to the Professional Services Council FedHealth Conference, March 11, 2020

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March 10, 2021 at 10:31PM Section 8400: Marketing Applications

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

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March 08, 2021 at 08:45PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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Justice: 'I'm not going to get in a food fight with Joe Manchin' on use of CARES Act funds | TheHill - The Hill

1. Justice: 'I'm not going to get in a food fight with Joe Manchin' on use of CARES Act funds | TheHill  The Hill
2. New Jersey Governor Phil Murphy says nursing homes who didn't follow virus guidance should "pay a…  Face the Nation
3. New Jersey governor: 'I'm confident in the numbers' on nursing home outbreaks | TheHill  The Hill
4. Open: This is "Face the Nation," March 7  Face the Nation
5. Face The Nation: Ben Crump, Liz Palmer, Scott Gottlieb  Face the Nation
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It's Time To Say Goodbye To Call Of Duty: Modern Warfare - GameSpot

1. It's Time To Say Goodbye To Call Of Duty: Modern Warfare  GameSpot
2. Call Of Duty Lures A Fugitive Out Of Hiding, Leads To His Arrest  Screen Rant
3. How to Fix UI Error 10002 in Call of Duty Black Ops Cold War  DualShockers
4. The perfect Call of Duty zombies mode is here, and it's not Outbreak  PC Gamer
5. Black Ops Cold War players begging for nerfs to “overpowered” Flak Jacket perk  Dexerto
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COVID In Minnesota: UK Variant Outbreak Linked To Youth Sports In Carver County, Officials Recommend 2-Week Pause - CBS Minnesota

1. COVID In Minnesota: UK Variant Outbreak Linked To Youth Sports In Carver County, Officials Recommend 2-Week Pause  CBS Minnesota
2. Get the facts: What to know about the 3 COVID-19 vaccines currently authorized  KETV Omaha
3. 90.7% of Minnesotans vaccinated against COVID-19 are white | FOX 9 KMSP  FOX 9 Minneapolis-St. Paul
4. Minn. health officials report COVID-19 variant clusters in Carver Co., call for youth sports pause  Minneapolis Star Tribune
5. Virus variants spreading in 15 Minnesota counties, doctors investigating students and athletes  KARE11.com
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March 05, 2021 at 09:36PM Coronavirus (COVID-19) Update: March 5, 2021

Coronavirus (COVID-19) Update: March 5, 2021

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Mask mandates associated with drop in cases, deaths, CDC finds; Cuomo aides altered nursing home report: Latest COVID-19 updates - USA TODAY

1. Mask mandates associated with drop in cases, deaths, CDC finds; Cuomo aides altered nursing home report: Latest COVID-19 updates  USA TODAY
2. Great apes at San Diego Zoo become first non-humans to receive COVID-19 vaccine  CBS News
3. Great apes at the San Diego Zoo got coronavirus vaccines: ‘These animals are incredibly precious’  Washington Post
4. 9 great apes get COVID-19 vaccinations following outbreak at San Diego Zoo  KTLA
5. Great apes given Covid vaccines after outbreak at San Diego zoo  The Guardian
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Great apes given Covid vaccines after outbreak at San Diego zoo - The Guardian

1. Great apes given Covid vaccines after outbreak at San Diego zoo  The Guardian
2. Great apes at San Diego Zoo become first non-humans to receive COVID-19 vaccine  CBS News
3. Cuomo administration reportedly concealed nursing home death count; San Diego Zoo vaccinates 9 great apes: Latest COVID-19 updates  USA TODAY
4. 9 great apes get COVID-19 vaccinations following outbreak at San Diego Zoo  KTLA
5. Orangutans, bonobos at San Diego Zoo receive experimental COVID-19 vaccine  The Week
6. View Full Coverage on Google News

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March 05, 2021 at 01:21PM CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

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March 04, 2021 at 05:40PM COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry

COVID-19 guidance

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March 04, 2021 at 04:52PM Flucelvax Quadrivalent

For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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Your daily 6: High school to close after outbreak; transgender sports ban hearing; Fauci warns against loosening restrictions - STLtoday.com

Your daily 6: High school to close after outbreak; transgender sports ban hearing; Fauci warns against loosening restrictions  STLtoday.com

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Brazil's COVID Crisis Is a Warning to the Whole World, Scientists Say - Yahoo News

1. Brazil's COVID Crisis Is a Warning to the Whole World, Scientists Say  Yahoo News
2. Brazil's COVID outbreak could open door to 'even more lethal variants'  New York Post
3. ‘A melting pot for variants.’ U.K., Brazilian, New York COVID strains found in Miami  Miami Herald
4. Raging pandemic shuts down Sao Paulo as Brazil nears Pfizer deal  Yahoo News
5. Brazil Reports Record High One-Day Coronavirus Death Toll  U.S. News & World Report
6. View Full Coverage on Google News

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March 03, 2021 at 08:49PM Xenotransplantation

Xenotransplantation is any procedure that involves the transplantation, implantation or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs.

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March 03, 2021 at 07:51PM FDA’s Data Modernization Action Plan: Putting Data to Work for Public Health

Data modernization is the next step in the agency’s overhaul of its approach to technology and data, and we are pleased to announce the Data Modernization Action Plan (DMAP).

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March 03, 2021 at 02:51AM 2021_03 Test Article FT 01

2021_03 Test Article some long description some long description.

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March 02, 2021 at 09:52PM Coronavirus (COVID-19) Update: March 2, 2021

Coronavirus (COVID-19) Update: March 2, 2021

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March 02, 2021 at 08:31PM FDA Voices on Consumer Safety and Enforcement

FDA Voices on Consumer Safety and Enforcement

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March 02, 2021 at 05:45PM National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams

The FDA is well-equipped to identify and thwart medical product scams while vaccine distribution is underway throughout the country.

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March 02, 2021 at 04:48PM Update on Amyotrophic Lateral Sclerosis (ALS) Product Development

This page describes the Update on Amyotrophic Lateral Sclerosis (ALS) Product Development

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March 02, 2021 at 12:26AM Cellular & Gene Therapy Products

CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.

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March 01, 2021 at 07:48PM Octaplas

Product approval information is indicated for Replacement of multiple coagulation factors in patients with acquired deficiencies
o due to liver disease
o undergoing cardiac surgery or liver transplant
Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP.

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March 01, 2021 at 04:32PM FDA Voices on Policy

FDA Voices on Policy

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March 01, 2021 at 02:40PM Rare Disease Day 2021: FDA Shows Sustained Support of Rare Disease Product Development During the Public Health Emergency

As the FDA focuses on the COVID-19 pandemic, the agency also remains dedicated to its crucial role in development of treatments for rare diseases.

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Virus Outbreak: News and Analysis From March 1 - Bloomberg

Virus Outbreak: News and Analysis From March 1  BloombergView Full Coverage on Google News

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