Approves First COVID-19 Vaccine

On August 23, 2021, the apconfirmed Comirnaty (COVID-19 Vaccine, mRNA), formerly well-known as Pfizer-BioNTech COVID-19 Vaccine, for the avoidance of COVID-19 illness in individuals 16 years of age and older. is working through U.S. federal government partners, including CDC, and also global partners to deal with the pandemic.

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Medical Devices

Radiation-Emitting Products

Vaccines, Blood, and Biologics

Animal and Veterinary


Tobacco Products


New Period of Smarter Food Safety

A brand-new technique to food safety that recognizes and also builds on the progress made in the past but looks in the direction of what processes and also tools will be essential for the future.


Fostering Drug Competition

Increasing the availability of generic drugs helps to create competition in the marketplace, helping make therapy even more affordable and also boosting access to healthtreatment for more patients.


Sep 02 In Brief: Reaches Milerock in Competitive Generic Therapy Drug Approvals

Sep 01 In Brief: to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster

Recalls, Market Withdrawals, & Safety Alerts

The gives indevelopment gathered from press releases and other public notices about certain recalls of assets. Not all recalls have actually press releases or are posted on this website

Sep 03

Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Systems 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency


Sep 02

Weis Markets Issues an Allergy Alert for $7 Crab Cake Meal Due to Unclaimed Milk Allergen

Food & Beverperiods

Sep 02

The Baking Institute Bakery Co. Issues Allergen Alert on Unasserted Walnuts, Coconuts and also Milk in “Carrot Cake”

Food & Beverages

*’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research

NCTR is celebrating 50 years of clinical accomplishments including the groundbreaking study we have done—and also proceed to do—in support of the’s mission.

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* Seeks Patient Insight: Call for Applications for the Patient Engagement Collaborative

The is announcing the speak to for applications for the next cohort of the Patient Engagement Collaborative.’s Budget: Medical Device Supply Chain and also Shortages Prevention Program

Investments outlined in’s FY 2022 budget will carry out resources to develop a long-term regimen for U.S. supply chain resilience for clinical tools.

Sep 01

Guidance for Industry: Microbiological Considerations for Antimicrobial Agents Used in Food Applications

Food & Beverages

Aug 31

Technical Specifications for Submitting Clinical Trial Documents Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)


Aug 30 Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

Biologics, Drugs, Medical Devices

Jobs at

Inspections and Compliance

MedWatch: Safety Alerts

Science & Research Organization

Import Program

Warning Letters

Combicountry Products

What does regulate?

Criminal Investigations

Disposal of Unused Medicines

Emergency Preparedness

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