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March 30, 2020

Drug Trials Snapshots: AIMOVIG

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 27, 2020

Safely Using Hand Sanitizer

Image Each of us can help stop the spread of COVID-19 disease by washing our hands regularly with soap and water for 20 seconds – especially […]
March 27, 2020

Corona-cure.com – 605875 – 03/26/2020

Product: Drugs Date:               March 26, 2020 RE:                 Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the […]
March 27, 2020

Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements

Docket Number: 98-0276 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
March 27, 2020

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry

Docket Number: FDA-2020-D-1057 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
March 27, 2020

Carahealth – 605826 – 03/26/2020

Product: Drugs Date:               March 26, 2020 RE:                 Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the […]
March 27, 2020

Research Tools and Resources

Developing and sharing knowledge with researchers from the public and private sectors is at the heart of what Center for Drug Evaluation and Research (CDER) scientists […]
March 27, 2020

Regulatory Science at CDER

Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. CDER’s regulatory science […]
March 26, 2020

Dr. Reddy’s Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Summary Company Announcement Date: March 26, 2020 FDA Publish Date: March 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Ampules breaking & shattering […]
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