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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
Sep 09
FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted
Sep 09
FDA In Brief: As Consumers Order More Meals and Groceries Online, FDA Plans Public Meeting to Address Food Safety Risks
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
Sep 08
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
Drugs
Sep 03
ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particulate Matter
Drugs
Sep 03
Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
Drugs
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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS
FDA’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research
NCTR is celebrating 50 years of scientific achievements including the groundbreaking research we have done—and continue to do—in support of the FDA’s mission.
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.
Recently Published Guidances
Sep 09
Withdrawn CDER Product Specific Guidances
Drugs
Sep 08
ICH Q12: Implementation Considerations for FDA-Regulated Products
Biologics, Drugs, Medical Devices
Sep 08
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Drugs