Featured Topics
FDA’s Technology Modernization Action Plan
The plan describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data, and analytics—to advance FDA’s public health mission.
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
Nov 15
Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
Nov 15
FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease
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
Nov 19
Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.
Drugs
Nov 15
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Drugs
Nov 15
Select Varieties of Breakstone’s Cottage Cheese are Voluntarily Being Recalled Due to Potential Presence of Foreign Material
Food & Beverages
FDA Voices: Perspectives from FDA Experts
Patient Engagement, Awareness and Medical Device Cybersecurity
To help better communicate medical device cybersecurity risks to patients, the FDA goes straight to the source.
Patient Perspective Is Vital to FDA's Work
FDA considers patients the real experts when it comes to their health conditions, as illustrated in the recent rare disease disorder summit.
To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality
Drug manufacturers with very high reliability usually have a mature quality management system — purchasers should have the ability to readily identify them.
Recently Published Guidances
Nov 20
CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances
Animal & Veterinary
Nov 15
Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry
Drugs
Nov 14
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
Medical Devices