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March 25, 2020

Data Standards Program Strategic Plan and Board

Strategic Plan CDER’s approach to data standards consists of four strategic goals: Support open, consensus-based data standards development Maintain and promote a well-defined data standards governance […]
March 25, 2020

CDER Data Standards Program

Each year, CDER receives more than 150,000 submissions, amounting to millions of pieces of data. CDER reviews the data to bring lifesaving new drugs to market […]
March 25, 2020

Compliance Policy Guide Section 110.800 Post Detention Sampling Guidance for Industry

Issued by: Guidance Issuing Office Office of the Associate Commissioner for Regulatory Affairs This guidance is for immediate implementation. FDA is issuing this guidance for immediate […]
March 25, 2020

FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data

For Immediate Release: January 29, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs – Food and Drug Administration Stephen M. Hahn M.D. […]
March 25, 2020

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

For Immediate Release: January 09, 2020 Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be […]
March 25, 2020

FDA approves new treatment for adults with migraine

For Immediate Release: December 23, 2019 The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or […]
March 25, 2020

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

For Immediate Release: December 19, 2019 The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of […]
March 25, 2020

Trump Administration takes historic steps to lower U.S. prescription drug prices

For Immediate Release: December 18, 2019 Français Today, President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug […]
March 25, 2020

FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

For Immediate Release: December 13, 2019 Español The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy […]
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