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
Aug 06
KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5mL Due to Temperature Abuse
Aug 04
Eco-Med Pharmaceutical Issues Voluntary Recall of Eco-Gel 200
Medical Devices
Aug 04
DSD Merchandisers, Inc. Issues Allergy Alert on Undeclared Peanuts in Dark Chocolate Malt Balls 9oz Tub
Food & Beverages
FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
FDA Seeks Patient Insight: Call for Applications for the Patient Engagement Collaborative
The FDA is announcing the call for applications for the next cohort of the Patient Engagement Collaborative.
FDA’s Budget: Medical Device Supply Chain and Shortages Prevention Program
Investments outlined in FDA’s FY 2022 budget will provide resources to establish a permanent program for U.S. supply chain resilience for medical devices.
Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines
A major paradigm shift is necessary from the systemic exclusion to the inclusion of pregnant and breastfeeding women in clinical studies.
Recently Published Guidances
Aug 06
Development and Submission of Near Infrared Analytical Procedures
Drugs
Aug 06
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials
Drugs
Jul 28
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry
Drugs