CDER SBIA Update: Participate in Stakeholder Meetings on GDUFA Reauthorization

 Request for Notification of Stakeholder Intention to Participate in Stakeholder Meetings on GDUFA Reauthorization

FDA would like to receive input on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA), the statutory authority for which expires in September 2017.  FDA would like to consult with a range of public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, in developing recommendations for the next GDUFA program.  To begin the reauthorization process, FDA is holding a public meeting on June 15, 2015, to gather input on the next GDUFA program.

FDA published a Federal Register notice seeking stakeholder participation in periodic consultation meetings with FDA on the reauthorization of GDUFA.  FDA will hold continued discussions with patient and advocacy groups during negotiations with regulatory industry to establish consistent stakeholder representation. 

FDA invites public stakeholders who wish to participate in continued periodic stakeholder consultation meetings regarding GDUFA reauthorization to notify FDA by email to GenericDrugPolicy@fda.hhs.gov by August 14, 2015.  Your email should contain complete contact information, including name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of a disability.

Sign Up for Email Alerts about GDUFA