[Ip-health] Federal Register :: Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting; Request for Comments

Jamie Love james.love at keionline.org
Thu Jun 22 09:15:50 PDT 2017

This is the federal register notice on the July 18 meeting at the FDA on
the Hatch/Waxman Act amendments



The Food and Drug Administration (FDA or the Agency) is announcing the
following meeting: “The Hatch-Waxman Amendments: Ensuring a Balance Between
Innovation and Access.” This public meeting is intended 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.


The meeting will be held on July 18, 2017, from 9 a.m. to 5 p.m. The
deadline for submitting comments regarding this meeting is September 18,


The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire
Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring,
MD 20993. Entrance for the public meeting participants (non-FDA employees)
is through Building 1, where routine security check procedures will be
performed. For parking and security information, please refer to


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