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FDA COVID-19 RESPONSE
FDA is working with U.S. government partners, including CDC, and international partners to address the pandemic.
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 27
Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
Drugs
Aug 26
Rocky Top Farms Issues Allergy Alert on Undeclared Milk in “Cherry Butter”
Food & Beverages
Aug 26
Top Quality Dog Food Recalls Batch Of “Beef HVM” 1-Pound Packages with Lot Number 071521, Because of Possible Salmonella, Listeria Monocytogenes Health Risk
Animal & Veterinary
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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 31
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Drugs
Aug 30
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
Biologics, Drugs, Medical Devices
Aug 30
Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway
Medical Devices