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March 19, 2020

Drug Trials Snapshots: LUTATHERA

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 19, 2020

Drug Trials Snapshots: NURTEC ODT

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 19, 2020

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

Docket Number: FDA-2008-D-0610 Issued by: Guidance Issuing Office Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition Office of Medical Products and […]
March 19, 2020

FDA Drug Competition Action Plan

Bringing more drug competition to the market and addressing the high cost of medicines is a top priority of the Administration, the Department of Health and […]
March 19, 2020

Drug Development Tool Submissions Process

As part of an ongoing effort to modernize FDA interactions with requestors and facilitate collaborative and innovative drug development tool qualification, CBER and CDER have launched […]
March 19, 2020

FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections

[12-4-2015] A U.S. Food and Drug Administration (FDA) safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes […]
March 18, 2020

Drug Trials Snapshots: BALVERSA

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 18, 2020

FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop – 05/04/2020 – 05/04/2020

On This Page Date: May 4, 2020 Time: 8:30 AM – 4:30 PM ET Meeting Information Date: Monday, May 4, 2020, from 8:30 – 4:30pm Location: […]
March 18, 2020

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Docket Number: FDA 2020-D-1106 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and […]
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