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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.
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
Jan 16
Yes To Inc. Issues Voluntary Recall of Product Due to Skin Irritation Complaints ‘Grapefruit Vitamin C Glow Boosting Unicorn Paper Mask’
Cosmetics
Jan 15
FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility
Drugs
Jan 13
Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Food & Beverages
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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
FDA Harnesses Technology and Collaboration to Support Rare Disease Product Development
Announcing an Orphan Drug Technology Modernization effort and the 2020 FDA Rare Disease Day meeting
Outbreaks Emphasize the Importance of Implementing Produce Safety Standards
Our commitment to advancing produce safety is unwavering.
Innovation in New Drug Approvals of 2019 Advances Patient Care Across a Broad Range of Diseases
In 2019, the FDA approved a wide variety of new drug therapies to help patients in need.
Recently Published Guidances
Jan 15
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers
Biologics, Drugs
Jan 13
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions
Medical Devices
Jan 02
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization
Tobacco