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

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



New CDER Conversation

Starting with tomorrow’s public meeting, 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. 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.

Read More