February 28, 2025 at 10:14PM Seasonal Information for Influenza Virus Vaccine

Seasonal Information for Influenza Virus Vaccine

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February 28, 2025 at 10:11PM FDA Plans for Selecting Influenza Virus Strains for Vaccine Composition for the 2025-2026 U.S. Influenza Season

FDA Plans for Selecting Influenza Virus Strains for Vaccine Composition for the 2025-2026 U.S. Influenza Season

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Are egg producers inflating prices during the bird flu outbreak to boost profits? - The Associated Press

1. Are egg producers inflating prices during the bird flu outbreak to boost profits?  The Associated Press
2. Trump’s got a bird flu plan. So when will eggs stop costing so much?  CNN
3. Opinion | Agriculture Secretary Brooke Rollins: My Plan to Lower Egg Prices  The Wall Street Journal
4. Egg Crisis Forces Trump to Seek Bigger Imports  Bloomberg
5. It’s Weird That Eggs Were Ever Cheap  The Atlantic

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Are egg producers inflating prices during the bird flu outbreak to boost profits? - The Associated Press

1. Are egg producers inflating prices during the bird flu outbreak to boost profits?  The Associated Press
2. Egg Crisis Forces Trump to Seek Bigger Imports  Bloomberg
3. Trump’s got a bird flu plan. So when will eggs stop costing so much?  CNN
4. Opinion | Agriculture Secretary Brooke Rollins: My Plan to Lower Egg Prices  The Wall Street Journal
5. It’s Weird That Eggs Were Ever Cheap  The Atlantic

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US will spend up to $1B to combat bird flu, USDA secretary says - KSL.com

1. US will spend up to $1B to combat bird flu, USDA secretary says  KSL.com
2. Trump’s got a bird flu plan. So when will eggs stop costing so much?  CNN
3. Are egg producers inflating prices during the bird flu outbreak to boost profits?  The Associated Press
4. Opinion | Agriculture Secretary Brooke Rollins: My Plan to Lower Egg Prices  The Wall Street Journal
5. It’s Weird That Eggs Were Ever Cheap  The Atlantic

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US will spend up to $1B to combat bird flu, USDA secretary says - KSL.com

1. US will spend up to $1B to combat bird flu, USDA secretary says  KSL.com
2. Trump’s got a bird flu plan. So when will eggs stop costing so much?  CNN
3. Are egg producers inflating prices during the bird flu outbreak to boost profits?  ABC News
4. CDC A(H5N1) Bird Flu Response Update February 26, 2025  CDC
5. Opinion | Agriculture Secretary Brooke Rollins: My Plan to Lower Egg Prices  The Wall Street Journal

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First death reported in Texas measles outbreak - POLITICO

1. First death reported in Texas measles outbreak  POLITICO
2. Child in West Texas is first US measles death in a decade  CNN
3. Texas measles outbreak results in hospitalizations, calls for vaccinations  CBS News
4. Unvaccinated Child Dies of Measles in Texas Outbreak  The New York Times
5. US reports first measles death since 2015  Al Jazeera English

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First case of measles reported in Rockwall County, health officials say - WFAA.com

1. First case of measles reported in Rockwall County, health officials say  WFAA.com
2. Child dies in measles outbreak in Texas as Washington officials urge vaccinations  KOMO News
3. Texas child is first reported US measles death in a decade as outbreak hits more than 130  Reuters
4. Unvaccinated Child Dies of Measles in Texas Outbreak  The New York Times
5. Texas measles outbreak results in hospitalizations, calls for vaccinations  CBS News

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First death reported in Texas measles outbreak - POLITICO

1. First death reported in Texas measles outbreak  POLITICO
2. Child in West Texas is first US measles death in a decade  CNN
3. Child dies in measles outbreak in Texas as Washington officials urge vaccinations  KOMO News
4. Unvaccinated Child Dies of Measles in Texas Outbreak  The New York Times
5. Measles death in Texas prompts vaccination warnings from Gulf Coast health officials  WEAR

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February 26, 2025 at 10:04PM MTS Anti-IgG, -C3d Card

Indicated For in vitro blood banking reagent

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February 26, 2025 at 04:35PM 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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February 26, 2025 at 01:20PM 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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February 25, 2025 at 03:20PM Sperm Bank, Inc. dba Fertility Center of California - 694273 - 02/14/2025

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

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February 24, 2025 at 04:13PM FDA 101: How to Use the Consumer Complaint System and MedWatch

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it.

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Recalled shakes reportedly kill 11 people, sicken 38 due to Listeria contamination - WKRC TV Cincinnati

1. Recalled shakes reportedly kill 11 people, sicken 38 due to Listeria contamination  WKRC TV Cincinnati
2. 11 deaths reported in listeria outbreak linked with supplemental shakes  CNN
3. Listeria outbreak that killed 11 linked to supplement shakes used at nursing homes, hospitals  USA TODAY
4. Frozen shakes sold to nursing homes recalled after listeria outbreak linked to 11 deaths  CBS News
5. Shakes sold to nursing homes recalled after listeria outbreak linked to 11 deaths  The Associated Press

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Fears grow as popular frozen shake used in nursing homes is recalled after 11 deaths - Daily Mail

1. Fears grow as popular frozen shake used in nursing homes is recalled after 11 deaths  Daily Mail
2. 11 deaths reported in listeria outbreak linked with supplemental shakes  CNN
3. Listeria outbreak that killed 11 linked to supplement shakes used at nursing homes, hospitals  USA TODAY
4. Shakes sold to nursing homes recalled after listeria outbreak linked to 11 deaths  The Associated Press
5. At least 11 deaths reported in listeria outbreak linked to supplemental shakes, FDA says  KKTV

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Listeria danger: FDA reports 11 deaths from contaminated frozen shakes - Scripps News

1. Listeria danger: FDA reports 11 deaths from contaminated frozen shakes  Scripps News
2. Listeria outbreak that killed 11 linked to supplement shakes used at nursing homes, hospitals  USA TODAY
3. At least 11 deaths reported in listeria outbreak linked to supplemental shakes, FDA says  KKTV
4. Frozen shakes sold to nursing homes recalled after listeria outbreak linked to 11 deaths  CBS News
5. Recalled shakes reportedly kill 11 people, sicken 38 due to Listeria contamination  ABC6OnYourSide.com

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February 21, 2025 at 09:13PM ABRYSVO

ABRYSVO is an active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older...

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February 21, 2025 at 04:49PM Biological Approvals by Year

A collection of biological approval information organized by year and regulatory authorities.

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February 21, 2025 at 03:35PM 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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February 20, 2025 at 08:50PM OTP Events, Meetings, and Workshops

Office of Therapeutic Products Events, Meetings, and Workshops

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February 20, 2025 at 04:53PM Have You Given Blood Lately?

The FDA works to ensure the safety of millions of units of blood and blood components donated in the U.S. each year. Learn how the FDA helps safeguard the blood supply and how you can donate blood.

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February 19, 2025 at 07:30PM Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This is the Draft Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)


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February 19, 2025 at 03:07PM eSubmitter Application History

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

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February 18, 2025 at 10:42PM Safety & Availability (Biologics)

Important information about the safety and availability of biological products.

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February 18, 2025 at 09:19PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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February 18, 2025 at 06:39PM 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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February 18, 2025 at 05:40PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under

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‘Wall Street of Eggs’ Experiences Surging Demand Thanks to Bird Flu - The Wall Street Journal

1. ‘Wall Street of Eggs’ Experiences Surging Demand Thanks to Bird Flu  The Wall Street Journal
2. New Orleans restaurants begin tacking on egg fees  Axios
3. Why egg-flation could end up being a headache for the Fed: Morning Brief  Yahoo Finance
4. Famous Los Angeles deli raising prices due to nationwide bird flu outbreak  KTLA Los Angeles
5. Amid bird flu, legendary L.A. deli hatches egg surcharge  Los Angeles Times

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February 12, 2025 at 04:13PM Increasing Options in Clinical Research to Facilitate Medical Product Development

FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research.

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February 12, 2025 at 03:37PM Realizing the Promise of Real-World Evidence

Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to better understand this area.

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February 15, 2025 at 12:28AM Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

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February 14, 2025 at 09:36PM Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement - 11/21/2024

This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) November 21, 2024 announcement and meeting materials.

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February 14, 2025 at 05:34PM 10 Facts about What FDA Does and Does Not Approve

Is It Really "FDA Approved"? Maybe you’ve seen these words on a company’s website or in a commercial promoting a product or treatment. Here are some facts about products that are, and aren’t, FDA approved.

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February 14, 2025 at 02:14PM Individual Case Safety Reports

This web page is dedicated to the health and regulatory data standard: Individual Case Safety Report

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February 13, 2025 at 06:50PM Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Lyme disease is on the rise. How can you prevent it? What are the symptoms, and what should you do if you think you or your pet have it?

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February 13, 2025 at 05:50PM Should Your Child Participate in a Clinical Trial?

Clinical trials give us important information about the safety and effectiveness of a treatment. Before deciding whether your child should join a clinical trial, learn as much as you can, including the risks and benefits.

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February 13, 2025 at 05:23PM POSTPONED: 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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February 12, 2025 at 10:49PM Know Your Treatment Options for COVID-19

Patients today have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use.

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February 12, 2025 at 04:13PM Increasing Options in Clinical Research to Facilitate Medical Product Development

FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research.

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February 12, 2025 at 03:37PM Realizing the Promise of Real-World Evidence

Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to better understand this area.

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February 12, 2025 at 04:01AM Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

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February 11, 2025 at 09:08PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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February 11, 2025 at 09:01PM 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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February 11, 2025 at 07:30PM 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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February 10, 2025 at 03:12PM The Concerning Trend in Men’s Health

Despite spending more on healthcare than any other nation on earth, life expectancy in the U.S. is trending downward.

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McDonald’s U.S. Sales Drop as Customers Spend Less - The Wall Street Journal

1. McDonald’s U.S. Sales Drop as Customers Spend Less  The Wall Street Journal
2. McDonald’s revenue disappoints as U.S. customers spend less at its restaurants  CNBC
3. McDonald's Sales Take a Hit After E. Coli Outbreak  Newsweek
4. McDonald’s Discounts Could Hurt Profit. Watch the Earnings on Monday.  Barron's
5. McDonald's posts biggest US sales decline in nearly five years  Yahoo Finance

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McDonald’s was having a rough 2024. An E. coli outbreak made it worse - CNN

McDonald’s was having a rough 2024. An E. coli outbreak made it worse  CNNView Full Coverage on Google News

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February 03, 2025 at 07:25AM Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, CBER, Biologics

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February 03, 2025 at 07:10AM Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications

This is the Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications, CBER, Biologics

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February 03, 2025 at 06:50AM Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001

This is the Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001.

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Tracking the prices of grocery staples amid trade talks, avian flu outbreaks - CNN

1. Tracking the prices of grocery staples amid trade talks, avian flu outbreaks  CNN
2. Why Donald Trump’s protectionist zeal has only grown  The Economist
3. The Early Verdict on Tariffs: Bad Economics, Better Politics  The Wall Street Journal
4. Stuck stock market is worried about economic growth as Trump's tariffs dominate headlines  CNBC
5. Here’s Where China’s Retaliatory Tariffs on the U.S. Could Hit Hardest  TIME

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February 07, 2025 at 10:16PM Description of FDA Forms for Export Certification

Description of FDA Forms for Export Certification

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February 07, 2025 at 05:48PM International Activities

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

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February 06, 2025 at 10:22PM 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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February 06, 2025 at 04:12PM 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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January 31, 2025 at 07:32PM Premarketing Risk Assessment

Guidance for Industry - Premarketing Risk Assessment, Clinical/Medical

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February 05, 2025 at 03:13PM Institutional Review Boards Frequently Asked Questions

IRB Information Sheet - Frequently Asked Questions

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February 05, 2025 at 02:49PM Evaluation of Sex Differences in Clinical Investigations

Evaluation of Sex Differences in Clinical Investigations - IRB Information Sheet

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February 04, 2025 at 09:48PM Blood & Blood Products

CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components. FDA has strengthened the safeguards that protect patients from unsuitable blood and blood products and has increased its oversight of t

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February 04, 2025 at 04:35PM Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

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February 04, 2025 at 03:20PM BioStem Life Sciences - 673788 - 01/17/2025

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

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Waffle House is placing a surcharge on every egg it sells - CNN

1. Waffle House is placing a surcharge on every egg it sells  CNN
2. Egg Shortages Are Now Hitting Restaurants, With No Relief in Sight  Bloomberg
3. Egg-flation leaves NYC eateries scrambling as costs quadruple: ‘I can’t keep this up’  New York Post
4. Egg prices have soared as farmers contend with bird flu outbreak  NBC News
5. Waffle House adds egg surcharge amid rising egg prices  FOX 5 Atlanta

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February 03, 2025 at 05:54AM Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials

Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, CBER, Biiologics

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February 03, 2025 at 05:41AM Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications

Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, CBER, Biologics

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February 03, 2025 at 05:25AM Preclinical Assessment of Investigational Cellular and Gene Therapy Products

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, CBER, Biologics


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February 03, 2025 at 05:05AM Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 Guidance for Industry, cber, biologics

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US egg prices expected to climb further as farmers strained by bird flu outbreak - The Guardian US

1. US egg prices expected to climb further as farmers strained by bird flu outbreak  The Guardian US
2. On the frontline against bird flu, egg farmers fear they're losing the battle : Shots - Health News  NPR
3. Increasing egg prices have Americans scrambling  CBS News
4. Considering owning chickens to combat cost of eggs? Here's what you should know  WKRC TV Cincinnati
5. N.Y. attorney general warns busi­nesses against price gouging amid rising egg costs  Spectrum News

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