May 12, 2022

FDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS)

Action FDA has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS). Radicava ORS is an orally administered version […]
May 12, 2022

FDA’s Overview of Catalyst Pharms., Inc. v. Becerra

On September 30, 2021, the U.S. Court of Appeals for the 11th Circuit issued a decision in Catalyst Pharms., Inc. v. Becerra (Catalyst)—a decision that impacts […]
May 12, 2022

From Our Perspective: FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time

By: Joseph Rajendran, M.D. (Medical Doctor), FASNC (Fellow of the American Society of Nuclear Cardiology), FACNM (Fellow of the American College of Nuclear Medicine), Medical Officer, […]
May 11, 2022

Generic Drugs Forum 2021: Lifecycle of a Generic Drug – 04/28/2021

Presentation Title Presenter(s) Keynote from Sally Choe, Director, Office of Generic Drugs (OGD) Sally ChoeDirectorOffice of Generic Drugs (OGD)CDER Office of Pharmaceutical Quality (OPQ) Update Sau […]
May 10, 2022

CDER Launches New Accelerating Rare disease Cures (ARC) Program

[5/10/2022] FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the new Accelerating Rare disease Cures (ARC) Program. The vision of CDER’s ARC […]
May 10, 2022

CDER’s ARC Program

Launched in May 2022, CDER’s Accelerating Rare disease Cures (ARC) Program harnesses CDER’s collective expertise and activities to provide strategic overview and coordination of CDER’s rare […]
May 10, 2022

2022 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments – 06/07/2022

On This Page Date: June 7, 2022 Time: 9:30 AM – 10:50 AM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]
May 10, 2022

Regulatory Counsel | Jobs at CDER

Please review each grade announcement for a list of job duties. Resolves a broad range of regulatory, scientific, and technical issues concerning the application of the […]
May 10, 2022

Project Specialist | Jobs at CDER

Description of Duties Identifies project activities or situations that may adversely impact project plans. Advises supervisor and senior management on recommended solutions to administrative conflicts or […]
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