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.
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
Jun 21
Prairie Wolf Spirits, Inc. Issues Voluntary Nationwide Recall of Prairie Wolf Distillery Hand Sanitizer Packed in 16.9 Oz. and 20 Oz Bottles Because They Resemble Drink Containers
Drugs
Jun 21
Bea Lydecker’s Naturals, Inc. Issues Allergy Alert on Undeclared Soy Lecithin in Living Free Dietary Supplement
Food & Beverages
Jun 19
Cuisine Solutions Issues Voluntary Recall of Flavored Plant-Based Bites
Food & Beverages
FDA VOICES: PERSPECTIVES FROM FDA EXPERTS

FDA’s Budget: Maternal and Infant Health and Nutrition
FDA’s FY 2022 budget includes important funding to core food safety programs and emerging issues of concern such as maternal and infant health and nutrition.

FDA’s Budget: Advancing the Goal of Ending the Opioid Crisis
FDA’s FY 2022 budget would address current public health needs and help FDA to tackle complex challenges such as those needed in addressing the opioid crisis.

Innovative Regenerative Medicine Therapies – Patient Safety Comes First
Cellular-derived therapies offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.
Recently Published Guidances
Jun 25
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Biologics, Drugs
Jun 24
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
Biologics, Drugs
Jun 24
Remanufacturing of Medical Devices
Medical Devices