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Vaccines.govFDA 2021 Year in Review - Working for You
Featured Topics
New Era of Smarter Food Safety
A new approach to food safety that recognizes and builds on the progress made in the past but looks towards what processes and tools will be needed for the future.
Fostering Drug Competition
Increasing the availability of generic drugs helps to create competition in the marketplace, helping make treatment more affordable and increasing access to healthcare for more patients.
Combating the Opioid Crisis
FDA takes actions to combat prescription opioid abuse.
Recent Press Announcements
Recalls, Market Withdrawals, & Safety Alerts
The FDA provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this website
Mar 21
Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect
Drugs
Mar 21
Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity
Drugs
Mar 20
Fruit Fresh Up, Inc Recalls Products due to Possible Health Risk
Food & Beverages
FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
CDER Continues to Make Rare Diseases a Priority with Drug Approvals and Programming to Speed Therapeutic Development
Over the past decade or so, we have seen an upward trajectory in the percentage of drugs approved to treat rare or “orphan” diseases.
Sharing Experiences in Rare Diseases Together
This year, the U.S. Food and Drug Administration is part of the worldwide community observing Rare Disease Week—February 28th through March 4th.
Innovation and Scientific Collaboration Moved the Generic Drug Program Forward In 2021
2021 was a productive year for the agency’s generic drug program.
Recently Published Guidances
Mar 22
An Acceptable Circular of Information for the Use of Human Blood and Blood Components
Biologics
Mar 22
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry
Biologics, Drugs, Medical Devices
Mar 15
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
Biologics