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  1. News & Events for Human Drugs

CDER Conversations

Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process

In this CDER Conversation, Sally Choe, director of the Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs and Mike Kopcha director of CDER’s Office of Pharmaceutical Quality discuss reauthorization of GDUFA.

Starting tomorrow, FDA begins the important process of considering public input, meeting with stakeholders, and engaging in negotiations with the generic drug industry as part of the process for Congress to reauthorize the Generic Drug User Fee Amendments (GDUFA) for another five years. Reauthorization of GDUFA will allow for critical funding of FDA’s generic drug program so the agency can continue to ensure Americans have access to safe, effective and high-quality generic drugs.

More with Sally Choe and Mike Kopcha

 


New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program

CDER Conversation with Robyn Bent, Director of Patient-Focused Drug Development and Program Officer for the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program

New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant ProgramReal world evidence has the potential to enhance the efficiency of drug development and provide new evidence on risks and benefits of medical products.

FDA considers the use of patient input an important part of medical product development that can foster innovation and the availability of safe and effective drugs.

More with Robyn Bent

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