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
Dec 11
Voluntary Recall of Howling Cow Butter Almond Ice Cream Due to Undeclared Soy and Wheat
Food & Beverages
Dec 10
Efficient Laboratories, Inc. Expands Voluntary Nationwide Recall to Consumers to Include Twelve Additional Lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM Sold in 2019 Due to Microbial Contamination Concerns
Drugs
Dec 10
Bokhary Foods Inc. (d.b.a EKTA Foods) Issues Alert on Undeclared Sulfites in Godavari Dried Apricots
Food & Beverages
FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
FDA Works to Strengthen Food Safety Protections as Consumers Increasingly Order Foods Online
FDA wants food safety measures that are as modern as the food delivery systems themselves.
How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program
To meet our public health mission, it is critical that FDA continues to evolve to help speed innovations that make medical products safer and more effective.
FDA’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients
FDA has established numerous initiatives, including the development of a research program to better understand the science of advanced manufacturing.
Recently Published Guidances
Dec 10
Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency
Biologics
Dec 10
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry
Drugs
Dec 10
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products
Drugs