On June 15, 2015, FDA held a public meeting to seek input on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA).The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA hold public meetings and conduct discussions with both the generic drug industry and patient and consumer advocacy groups in developing recommendations for the next GDUFA program (FY2018-2022).
The comment period for the GDUFA public meeting docket was open from April 21, 2015 through July 15, 2015.
Comments Submitted to the GDUFA Public Meeting Docket (FDA-2012-N-0882-0002)
- American Society of Anesthesiologists
- Aphena Pharma
- Areva Pharmaceuticals
- Bulk Pharmaceuticals Task Force
- Catalent Pharma Solutions
Center for Health Equity Research and Promotion
- Coalition for PET Drugs
- Fera Pharmaceuticals
- Generic Pharmaceutical Association_Comment (3.19.15)
- Generic Pharmaceutical Association_Comment (7.1.15)
- Generic Pharmaceutical Association_Comment (7.15.15)
- George Ward
- Hanford Pharmaceuticals
- Healthcare Supply Chain Association
- International Pharmaceutical Excipients Council of the Americas
- Kaiser Permanente
- Medical Imaging and Technology Alliance
- Murty Pharmaceuticals
- Small Startup Us based Pharma Company
- Specialty Pharma Association
- VPCI, Inc.