Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)
November 16, 2021
- November 16, 2021
FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027. The virtual public meeting will be held on November 16, 2021, from 9 a.m. to 2 p.m. ET. The meeting agenda, public docket information, additional materials, and any other updates will also be posted to this website as they become available.
You can register for the meeting here. Registration is not required to view the meeting, however, registrants will receive email updates and notices when new information becomes available. If you wish to present during a public comment session, please submit your request to GenericDrugPolicy@fda.hhs.gov by 11:59 p.m. ET on November 8, 2021.
Date: November 16, 2021
Time: 9:00 AM - 2:00 PM ET
Zoom meeting link
Webinar Meeting ID:
160 003 0426
Webinar Password (Case-Sensitive):
|GDUFA III Commitment Letter||pdf (295.26 KB)|
|GDUFA III Public Meeting Agenda 11.16.21||pdf (149.69 KB)|
|GDUFA III Fall Public Meeting 11 16 2021 slides||pdf (3.13 MB)|
|Transcript of GDUFA III Public Meeting||pdf (213.71 KB)|
|Summary of views and comments received regarding proposed recommendations for GDUFA III||pdf (214.33 KB)|