Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting


“Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access” was a meeting held on July 18, 2017 to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained. Further information, including questions for stakeholder input, can be found in the public meeting notice. Public comments will be accepted through September 18, 2017 at the Public Docket, FDA-2017-N-3615.


July 18, 2017


9:00 a.m. to 5:00 p.m.


FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
Great Room (Rm. 1503)
Silver Spring, MD 20993
Public Meetings at FDA White Oak Campus

Meeting Materials:

Meeting Recordings:


Additional presentations have been submitted by some presenters to the Public Docket, FDA-2017-N-3615

For Further Information, Contact:

Philip Bonforte
Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993
Phone: 240-402-6980
Email: GenericDrugPolicy@fda.hhs.gov


Page Last Updated: 07/20/2017
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