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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
Oct 14
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity
Drugs
Oct 12
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency
Drugs
Oct 11
Tuffy’s Pet Foods; Inc. Issues Voluntary Recall of a Limited Quantity of Pure Vita Salmon Entrée Dog Food in a Tetrapak Carton Due to Potentially Elevated Levels of Vitamin D
Animal & Veterinary
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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
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.
Advancing the Development of Innovative Veterinary Products
FDA takes a proactive approach to provide timely and efficient review of innovative medical products for animals.
Recently Published Guidances
Oct 20
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
Medical Devices
Oct 19
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
Medical Devices
Oct 14
Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
Biologics, Medical Devices