February 01, 2025 at 12:53AM Data Standards for Drug and Biological Product Submissions Containing Real-World Data

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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February 01, 2025 at 12:32AM Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.

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January 31, 2025 at 10:16PM Human Gene Therapy for Hemophilia

Human Gene Therapy for Hemophilia, Draft Guidance for Industry, CBER, biologics

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January 31, 2025 at 06:32PM It’s a Good Time to Get Your Flu Vaccine

Getting vaccinated in the fall can lower your chances of getting the flu. Haven’t had your flu shot yet? It’s not too late. Every flu season is different. Your best defense against the flu is to get a vaccine every year.

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January 31, 2025 at 04:05PM SPIKEVAX

COVID19 Vaccine, mRNA

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January 31, 2025 at 03:01PM Evaluation of Sex Differences in Clinical Investigations

Evaluation of Sex Differences in Clinical Investigations - IRB Information Sheet

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January 30, 2025 at 10:08PM Patient Listening Session Summaries

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

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January 30, 2025 at 08:37PM Clinical Review - Fluarix

•For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine.

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January 30, 2025 at 08:11PM Final Statistical Review and Evaluation - Novoeight

Product approval information is indicated for control and prevention of bleeding episodes in adults, adolescents and children with hemophilia A; perioperative management of patients with hemophilia A; routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults, adolescents

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January 28, 2025 at 09:31PM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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January 28, 2025 at 03:20PM Evolutionary Biologics Inc. - 681586 - 12/30/2024

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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The CIA believes COVID most likely originated from a lab but has low confidence in its own finding - The Associated Press

1. The CIA believes COVID most likely originated from a lab but has low confidence in its own finding  The Associated Press
2. New CIA boss Ratcliffe says Biden-era report backing lab-leak theory released to 'restore' trust  Fox News
3. CIA becomes latest intel agency to conclude COVID-19 likely originated from Chinese lab leak  New York Post
4. CIA shifts assessment on Covid origins, saying lab leak likely caused outbreak  NBC News
5. C.I.A. Now Favors Lab Leak Theory to Explain Covid’s Origins  The New York Times

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Eggs are pricey again. What’s the government doing about it? - Vox.com

1. Eggs are pricey again. What’s the government doing about it?  Vox.com
2. Expect record-high egg prices for most of the year  CNN
3. Wind-blown avian feces may be route of transmission for bird flu, Minnesota's infectious disease expert warns  CBS Minnesota
4. Egg prices 2025: Growing bird flu outbreak causing shortages, higher prices  Axios
5. Egg shortage, higher prices caused by spike in bird flu cases affecting millions of chickens  WMUR Manchester

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CIA says that Covid-19 probably leaked from Chinese laboratory - Financial Times

1. CIA says that Covid-19 probably leaked from Chinese laboratory  Financial Times
2. CIA shifts assessment on Covid origins, saying lab leak likely caused outbreak  NBC News
3. C.I.A. Now Favors Lab Leak Theory to Explain Covid’s Origins  The New York Times
4. CIA Now Favors Lab Leak Theory on Origins of Covid-19  The Wall Street Journal
5. The CIA believes COVID most likely originated from a lab but has low confidence in its own finding  The Associated Press

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CIA shifts assessment on Covid origins, saying lab leak likely caused outbreak - NBC News

1. CIA shifts assessment on Covid origins, saying lab leak likely caused outbreak  NBC News
2. CIA Now Favors Lab Leak Theory on Origins of Covid-19  The Wall Street Journal
3. CIA says that Covid-19 probably leaked from Chinese laboratory  Financial Times
4. C.I.A. Now Favors Lab Leak Theory to Explain Covid’s Origins  The New York Times
5. CIA Shifts View on Covid-19 Cause With Lab Leak as ‘More Likely’  Bloomberg

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January 24, 2025 at 04:38PM Webinars and Outreach

CBER sponsored webinars for public and industry.

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Travel, grant and funding cuts ‘stifling’ US health agencies in new Trump era - The Guardian US

1. Travel, grant and funding cuts ‘stifling’ US health agencies in new Trump era  The Guardian US
2. Health researchers alarmed as Trump administration pauses travel, communications  The Washington Post
3. FDA pauses updates on foodborne outbreak probes as health agencies regroup on communications  CBS News
4. ‘Never seen anything like this’: Trump’s team halts NIH meetings and travel  Nature.com
5. Swaths of U.S. Government Grind to a Halt After Trump Shock Therapy  The Wall Street Journal

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January 23, 2025 at 02:57PM Clinical Guidances

This page lists Clinical Guidance documents.

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Fast growing fire breaks out in Castaic, prompting evacuations - LAist

1. Fast growing fire breaks out in Castaic, prompting evacuations  LAist
2. Mandatory evacuations ordered in northern LA County in first significant wildfire outbreak since fatal fires  CNN
3. California Wildfires Live Updates: New Fire Explodes North of Los Angeles, Forcing Evacuations  The New York Times
4. Brush fire ignites near Castaic  KTLA Los Angeles
5. Hughes fire explodes north of Castaic, forcing evacuations  Los Angeles Times

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January 22, 2025 at 08:15PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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January 21, 2025 at 04:50PM Abbott Laboratories - 669353 - 10/24/2023

Dietary Supplement/Adulterated


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January 20, 2025 at 06:30PM FDA Voices

Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

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Extreme cold forecast for much of US in coming days - The Associated Press

1. Extreme cold forecast for much of US in coming days  The Associated Press
2. Over 85 million Americans under cold weather alerts  ABC News
3. Temperatures will plummet as Arctic outbreak brings frigid weather to much of the U.S.  NBC News
4. Deep freeze expected to bring bitter cold temperatures to the US  TODAY
5. Polar vortex to blast 30 states with life-threatening cold: 'Be prepared'  Fox Weather

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January 16, 2025 at 07:11PM CBER Rare Disease Program

Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.

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January 16, 2025 at 05:51PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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January 16, 2025 at 02:59PM Vaccines and Related Biological Products Advisory Committee December 12, 2024 Meeting Announcement - 12/12/2024

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) December 12, 2024 meeting announcement and materials.

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January 15, 2025 at 02:41PM Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma - 02/19/2025

This webinar is intended to provide blood establishments and other stakeholders with an overview of OBRR’s approach to the review of biologics license applications for the manufacture of blood and blood components, including source plasma. In this event, OBRR staff will give presentations on select topics and address questions submitted by registra

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January 14, 2025 at 06:52PM Animal Welfare, Testing and Research of FDA-Regulated Products

FDA-regulated medical and veterinary products save lives. Products undergo different types of testing, including animal testing, to determine their safety and effectiveness. The FDA encourages and accepts scientifically valid alternatives to animal testing.

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January 14, 2025 at 03:40PM Regulatory Harmonization and Convergence

The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER.

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January 14, 2025 at 01:27PM Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER

Use of Artificial Intelligence and Machine Learning (AI/ML) has rapidly become an important component of everyday life. This includes using AI/ML in the development of Medical Products, including Biologics. This page provides an overview of CBER's activity in AI/ML.

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January 13, 2025 at 07:59PM OCMO Guidance Documents

Guidance documents are intended to assist industry and other interested parties in understanding regulatory expectations, complying with applicable laws, and developing new and innovative products that improve public health.

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January 13, 2025 at 06:22PM Vaccines for COVID-19: A Personal Reflection

Vaccines for Covid-19: A Personal Reflection by Robert M. Califf, MD

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January 13, 2025 at 04:21PM Artificial Intelligence for Drug Development

FDA recognizes the increased use of AI throughout the drug development process and across a range of therapeutic areas. Learn more.

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January 13, 2025 at 03:41PM Devices Guidances

This page lists Medical Device Guidance documents.

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USDA report finds Boar's Head listeria outbreak was due to poor sanitation practices - NPR

USDA report finds Boar's Head listeria outbreak was due to poor sanitation practices  NPRView Full Coverage on Google News

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January 10, 2025 at 04:26PM Clinical Investigator Inspection List A-D

Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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January 10, 2025 at 04:25PM Clinical Investigator Inspection List E-K

Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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January 10, 2025 at 04:19PM Clinical Investigator Inspection List L-P

Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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January 10, 2025 at 04:15PM Clinical Investigator Inspection List Q-S

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

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January 08, 2025 at 07:18PM Antimicrobial Resistance

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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January 08, 2025 at 05:47PM Administrative Guidances

This page lists Administrative Guidance documents.

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January 08, 2025 at 03:43PM Create and Keep a Medication List for Your Health

Keeping track of when, how and why you use medications is important for your health and safety. A medication list helps you track all the prescription medications, over-the-counter (OTC) drugs, vitamins and supplements that you take. The list can be a lifesaver, especially during an emergency.

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January 07, 2025 at 03:20PM XO Biologix, LLC - 697717 - 12/12/2024

Unapproved New Drugs/Adulterated


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What We Know About HMPV, the Virus Spreading in China - The New York Times

1. What We Know About HMPV, the Virus Spreading in China  The New York Times
2. HMPV Virus Cases Live Updates: Two suspected cases of HMPV detected in Nagpur  The Times of India
3. What is human metapneumovirus, are cases surging in China, and should we be worried?  The Guardian
4. HMPV virus - latest: Cases begin rising across parts of world after outbreak in China  The Independent
5. Overblown fears of HMPV cases in China reflect pandemic scars  The Washington Post

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What We Know About HMPV, the Virus Spreading in China - The New York Times

1. What We Know About HMPV, the Virus Spreading in China  The New York Times
2. HMPV virus - latest: India authorities step up monitoring after new outbreak in China  The Independent
3. What to know about metapneumovirus—the respiratory infection you've never heard of that spiked this spring  Fortune
4. What is human metapneumovirus, are cases surging in China, and should we be worried?  The Guardian
5. HMPV Virus Cases Live Updates: Two suspected cases of HMPV detected in Nagpur  The Times of India

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Overblown fears of HMPV cases in China reflect pandemic scars - The Washington Post

1. Overblown fears of HMPV cases in China reflect pandemic scars  The Washington Post
2. What is HMPV? China steps up monitoring amid new virus outbreak  The Independent
3. HMPV in India: 5 cases identified so far, know the symptoms across all age groups  The Times of India
4. What is HMPV, and should we fear another pandemic?  NewsNation Now
5. A respiratory virus is spreading in China. Here's why it's not the new COVID-19.  Business Insider

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January 06, 2025 at 03:41PM Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

This draft guidance provides recommendations regarding the contents of marketing submissions for devices that include AI-enabled device software functions.


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January 06, 2025 at 03:41PM Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This is the Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

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January 06, 2025 at 01:40PM Cleared 510(k) Submissions with Supporting Documents

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

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Millions face snow and ice as a major winter storm moves across the U.S. - NPR

1. Millions face snow and ice as a major winter storm moves across the U.S.  NPR
2. Blair Prompts Blizzard, Winter Storm Warnings  The Weather Channel
3. Cities that rarely get snow are getting more than a foot in frigid 'arctic outbreak'  Yahoo! Voices
4. Live updates: Cities close schools, warn drivers to stay off roads as winter storm brings snow, sleet and ice  NBC News
5. The heaviest snowfall in a decade is possible as a wintry blast roils parts of the US  The Associated Press

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Arctic blast to accompany major winter storm, send temperatures plunging for 230 million - Axios

1. Arctic blast to accompany major winter storm, send temperatures plunging for 230 million  Axios
2. Temperatures Plummet Due to Arctic Blast To Kick Off The New Year  The Weather Channel
3. It’s about to get dangerously cold, even for winter  CNN
4. An Arctic outbreak will send a chill through much of the U.S. Here's how to prepare  NPR
5. Polar Vortex Maps Show How Far Temperatures Could Plunge in Each State  Newsweek

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Cold Snap Is Forecast to Grip Much of the United States - The New York Times

1. Cold Snap Is Forecast to Grip Much of the United States  The New York Times
2. Temperatures Plummet Due to Arctic Blast To Kick Off The New Year  The Weather Channel
3. It’s about to get dangerously cold, even for winter  CNN
4. Multiple Arctic outbreaks to affect more than 250 million in central, eastern US into mid-January  Yahoo! Voices
5. An Arctic outbreak will send a chill through much of the U.S. Here's how to prepare  NPR

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Cold Snap Is Forecast to Grip Much of the United States - The New York Times

1. Cold Snap Is Forecast to Grip Much of the United States  The New York Times
2. Arctic Cold Outbreak To Blast South, Midwest, East Into Mid-January  The Weather Channel
3. Deep Freeze Will Send Some US Temperatures Plunging  Bloomberg
4. An Arctic outbreak will send a chill through much of the U.S. Here's how to prepare  NPR
5. 'Prolonged cold' expected in Texas as arctic blast descends  Chron

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January 03, 2025 at 02:30AM Biologics Guidances

This page displays links to Biologics Guidance documents.

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January 02, 2025 at 04:55PM Industry Frequently Asked Questions

Frequently asked questions and the associated answers sorted by topic area

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Arctic blast tied to polar vortex puts U.S., Europe in deep freeze - Axios

1. Arctic blast tied to polar vortex puts U.S., Europe in deep freeze  Axios
2. Multiple Arctic outbreaks to affect more than 250 million in central, eastern US into mid-January  Yahoo! Voices
3. Polar vortex to bring freezing weather to US  BBC.com
4. Temperatures Plummet Due to Arctic Blast To Kick Off The New Year  The Weather Channel
5. Much of the U.S. bracing for a big blast of winter — and serious cold  NBC News

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January 02, 2025 at 03:25PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2025

This is the list of guidance topics CBER is considering for development during Calendar Year 2025

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Much of the U.S. bracing for a big blast of winter — and serious cold - NBC News

1. Much of the U.S. bracing for a big blast of winter — and serious cold  NBC News
2. Multiple Arctic outbreaks to affect more than 250 million in central, eastern US into mid-January  Yahoo! Voices
3. NYC winter storm forecast: 'Potential for heavy snow' in area next week  FOX 5 New York
4. When will polar vortex reach Texas? Arctic blast to bring freezing temps on Monday  Austin American-Statesman
5. Polar vortex is coming; what it is and when to expect the cold  NorthJersey.com

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