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  1. News & Events for Human Drugs

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

In the Federal Register (FR) of June 22, 2017 (82 FR 28493), FDA published a notice of public meeting with a 60-day comment period to request comments on the appropriate balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs.  After receiving extension requests to allow interested persons additional time to comment, FDA has extended the comment period. Please submit electronic or written comments to Docket FDA-2017-N-3615 by November 17, 2017. Further information can be found in the extension of comment period notice.

Summary:

“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 November 17, 2017 at the Public Docket, FDA-2017-N-3615.

Date:

July 18, 2017

Time:

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

Location:

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:

Presentations:

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

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