December 31, 2024 at 05:34PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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December 30, 2024 at 09:51PM ACAM2000

ACAM2000 is a product approval indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

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Scattered showers possible after severe weather moved through Sunday morning - WYFF4 Greenville

1. Scattered showers possible after severe weather moved through Sunday morning  WYFF4 Greenville
2. Georgia, Carolinas face tornado threat as deadly severe weather outbreak continues charge across Southeast  Fox Weather
3. Tornado Watch canceled in metro Atlanta, north Georgia  WSB Atlanta
4. FIRST ALERT TODAY: Severe storms exit the CSRA but rain continues  WRDW
5. National Weather Service issues severe thunderstorm warning in Piedmont Triad  WGHP FOX8 Greensboro

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1 killed, 4 injured in tornado-warned storm in Liverpool in Brazoria County - KHOU.com

1. 1 killed, 4 injured in tornado-warned storm in Liverpool in Brazoria County  KHOU.com
2. Tornadoes rip through South as destruction seen in multiple states amid deadly severe weather outbreak  Fox Weather
3. Texas tornado confirmed in Brazoria County causes severe damage near Alvin  ABC13 Houston
4. Twister tears through North Katy: Homes destroyed, vehicles flipped - but mordaciously no injuries  KPRC Click2Houston
5. Severe weather takes a deadly turn in the U.S. South as tornadoes touch down  NPR

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Tornado outbreak targets the South as winter storm forms - Axios

Tornado outbreak targets the South as winter storm forms  AxiosView Full Coverage on Google News

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Severe weather takes a deadly turn in the U.S. South as tornadoes touch down - NPR

1. Severe weather takes a deadly turn in the U.S. South as tornadoes touch down  NPR
2. Tornadoes rip through South as destruction seen in multiple states amid deadly severe weather outbreak  Fox Weather
3. Twister tears through North Katy: Homes destroyed, vehicles flipped - but mordaciously no injuries  KPRC Click2Houston
4. Texas tornado confirmed in Brazoria County causes severe damage near Alvin  ABC13 Houston
5. VIDEOS: Damage after tornadoes, storms move across Houston area  FOX 26 Houston

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Tornado outbreak targets the South as winter storm forms - Axios

1. Tornado outbreak targets the South as winter storm forms  Axios
2. Tornado Outbreak 'Likely' In The South Through Saturday Night, NOAA's Storm Prediction Center Says  The Weather Channel
3. 17 million under threat as South braces for more storms and tornadoes  NBC News
4. Mid-day Severe Weather Update For Alabama  alabamawx.com
5. STORMtracker Alert: Strong to severe storms this evening and tonight  Fox 10 News

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Tornado outbreak targets the South as winter storm forms - Axios

1. Tornado outbreak targets the South as winter storm forms  Axios
2. Tornado Outbreak 'Likely' In The South Through Saturday Night, NOAA's Storm Prediction Center Says  The Weather Channel
3. 17 million under threat as South braces for more storms and tornadoes  NBC News
4. Mid-day Severe Weather Update For Alabama  alabamawx.com
5. Rain and gusty winds today, flooding and damaging winds tonight  Local 3 News

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December 28 Weekend Rain May Include Thunder With Tornado Outbreak In The Deep South - Just In Weather

1. December 28 Weekend Rain May Include Thunder With Tornado Outbreak In The Deep South  Just In Weather
2. Risk of strong tornadoes grows for millions across South as storms develop in Texas  Fox Weather
3. Severe storms in Alabama Saturday evening through Sunday morning  WVTM13 Birmingham
4. STORMtracker Alert: Strong to severe storms this evening and tonight  Fox 10 News
5. Rain and gusty winds today, flooding and damaging winds this evening  Local 3 News

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December 27, 2024 at 09:46PM FDA Roundup: December 27, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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December 27, 2024 at 05:38PM Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document

Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document

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December 27, 2024 at 03:47PM Clinical Guidances

This page lists Clinical Guidance documents.

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December 26, 2024 at 07:20PM MRESVIA

Rolling BLA (Part 1 of 2) - Active immunization for the prevention of lower respiratory tract disease (LRTD) and acute respiratory disease (ARD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.


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December 21, 2024 at 12:10AM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

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December 20, 2024 at 08:28PM FDA Roundup: December 20, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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December 20, 2024 at 03:25PM FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities

FDA approved Symvess, the first acellular tissue engineered vessel for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

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December 19, 2024 at 10:21PM Executive Order 14017 on America’s Supply Chains

Updates on recommendations to help shore up the U.S. pharmaceutical supply chain, as directed by Executive Order 14017 on America’s Supply Chains

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December 19, 2024 at 01:26PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

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Gov. Gavin Newsom declares state of emergency amid bird flu outbreak - KTLA Los Angeles

1. Gov. Gavin Newsom declares state of emergency amid bird flu outbreak  KTLA Los Angeles
2. CDC confirms 1st case of severe bird flu in US  ABC News
3. California Governor Declares State Of Emergency Due To Bird Flu  NDTV
4. CDC Confirms First Severe Case of H5N1 Bird Flu in the United States  CDC
5. CDC confirms first severe human case of bird flu in U.S.  The Washington Post

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December 18, 2024 at 11:00PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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December 18, 2024 at 01:20PM Healthcare Providers (Biologics)

Resources for Healthcare Providers on biological products.

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December 17, 2024 at 11:36PM Fluzone and Fluzone High-Dose

Product approval information for Influenza Virus Vaccine

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December 17, 2024 at 10:20PM FDA Roundup: December 17, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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December 17, 2024 at 09:57PM Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during a pandemic.

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December 17, 2024 at 08:56PM 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 150,000 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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December 17, 2024 at 02:41PM Global Unique Device Identification Database (GUDID)

Provides information necessary for submitting data to the Global Unique Device Identification Database (GUDID). Primarily intended for device labelers.

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December 16, 2024 at 10:22PM Animal Rule Information

Learn more about the Animal Rule which may be used to grant marketing approval of certain products when human challenge studies are not ethical and human efficacy studies have not been feasible.

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December 16, 2024 at 05:07PM Facts About COVID-19 Vaccines

Facts about COVID-19 vaccines, including ingredients, safety and more

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December 13, 2024 at 10:35PM 2024 CBER Patient and Care Partner Listening Meetings

Gene therapy trials inform risks & benefits for informed decisions. Long-term follow-up crucial for safety & durability assessment.

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December 13, 2024 at 08:50PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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December 13, 2024 at 04:44PM Standards Development for Regenerative Medicine Therapies

Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies.

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December 13, 2024 at 03:05PM 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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December 12, 2024 at 09:22PM PAHO/WHO Collaborating Center

CBER has been a Pan American Health Organization (PAHO)/World Health Organization (WHO) Collaborating Center for Biological Standardization since 1998, formalizing its commitment to support the work of WHO after decades of scientific contributions.

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December 12, 2024 at 03:34PM 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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December 11, 2024 at 11:42PM Biologics Electronic Reading Room (eFOIA)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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December 11, 2024 at 10:37PM Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases

Gene therapy trials inform risks & benefits for informed decisions. Long-term follow-up crucial for safety & durability assessment.

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December 11, 2024 at 04:24PM 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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December 11, 2024 at 03:12PM Webinars and Outreach

CBER sponsored webinars for public and industry.

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December 10, 2024 at 10:50PM 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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December 10, 2024 at 10:00PM Consumer Updates

Science-based health and safety information you can trust.

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December 10, 2024 at 08:56PM FDA Roundup: December 10, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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December 10, 2024 at 02:36PM 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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December 09, 2024 at 09:56PM VISTASEAL

Fibrin Sealant lead page - FIBRIN SEALANT (Human) is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. FIBRIN SEALANT (Human)

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December 06, 2024 at 09:08PM FDA Roundup: December 6, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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December 06, 2024 at 02:45PM Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry

Guidance for Industry

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US closes investigation into E. coli outbreak linked to onions in McDonald's Quarter Pounders - The Associated Press

1. US closes investigation into E. coli outbreak linked to onions in McDonald's Quarter Pounders  The Associated Press
2. McDonald’s E. Coli Outbreak Declared Over  The New York Times
3. CDC says E. coli outbreak linked to McDonald's over  CBS News
4. Are onions safe to eat after the E. coli outbreak? What you must know  Fox News
5. E. coli outbreak tied to McDonald's Quarter Pounders has ended, CDC says  Reuters

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CDC issues major update about McDonald’s E. coli outbreak - New York Post

1. CDC issues major update about McDonald’s E. coli outbreak  New York Post
2. Are onions safe to eat after the E. coli outbreak? What you must know  Fox News
3. McDonald's Cleared by CDC After Investigation into Lethal E. Coli Outbreak  PEOPLE
4. E coli outbreak linked to McDonald's Quarter Pounders declared over: CDC  ABC7 Los Angeles
5. McDonald’s E. coli outbreak tied to fresh onions is over  Los Angeles Times

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December 03, 2024 at 09:52PM FDA Roundup: December 3, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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CDC says McDonald's E. coli outbreak is over - CNBC

1. CDC says McDonald's E. coli outbreak is over  CNBC
2. Are onions safe to eat after the E. coli outbreak? What you must know  Fox News
3. CDC declares McDonald’s E. coli outbreak over  New York Daily News
4. E. coli outbreak linked to McDonald's is over, CDC says  CBS News
5. McDonald's Cleared by CDC After Investigation into Lethal E. Coli Outbreak  PEOPLE

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CDC issues major update about McDonald’s E. coli outbreak - New York Post

1. CDC issues major update about McDonald’s E. coli outbreak  New York Post
2. Are onions safe to eat after the E. coli outbreak? What you must know  Fox News
3. McDonald's E. coli outbreak is over, CDC says  NBC News
4. E. coli outbreak linked to McDonald's onions is over after sickening 104, says CDC and FDA  USA TODAY
5. McDonald's Cleared by CDC After Investigation into Lethal E. Coli Outbreak  PEOPLE

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December 03, 2024 at 03:14PM Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions


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Recalled cucumbers may be linked to salmonella outbreak, health officials say - The Boston Globe

1. Recalled cucumbers may be linked to salmonella outbreak, health officials say  The Boston Globe
2. Cucumbers Are Recalled After Salmonella Sickens People in 19 States  The New York Times
3. Sunfed Produce, LLC Recalls Whole Fresh American Cucumbers Because of Possible Health Risks Due to Salmonella  FDA.gov
4. Cucumber recall: Throw out this vegetable sold in 26 states, including N.Y.  SILive.com
5. Investigation Update: Salmonella Outbreak, Cucumbers, November 2024  CDC

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Cucumbers Are Recalled After Salmonella Sickens People in 19 States - The New York Times

1. Cucumbers Are Recalled After Salmonella Sickens People in 19 States  The New York Times
2. Sunfed Produce, LLC Recalls Whole Fresh American Cucumbers Because of Possible Health Risks Due to Salmonella  FDA.gov
3. Thousands of cucumbers, eggs recalled over salmonella concerns  Fox Business
4. Cucumber recall: Throw out this vegetable sold in 26 states, including N.Y.  SILive.com
5. Recalled cucumbers may be linked to salmonella outbreak, health officials say  The Boston Globe

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