FDA Requests Stakeholder Participation in GUDFA Consultation Meetings

The FDA is asking stakeholders to notify the agency of their intention to participate in consultation meetings for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) of 2017.

The agency is planning monthly consultations with stakeholders, including the industry, advocacy groups, healthcare professionals and experts, to develop recommendations for the next GDUFDA program. The current five-year program, GDUFA II, is authorized through fiscal 2022, but it will need to be reauthorized to continue into future years. 

The meetings are expected to begin next month, and stakeholders are asked to sign up to participate by Oct. 8.