miércoles, 21 de junio de 2017

Invitation to attend and provide input - FDA’s public meeting on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access

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



Today, the Food and Drug Administration (FDA) announced a public meeting entitled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The 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. Further information, including questions for stakeholder input, can be found in the public meeting notice.
Participate
The meeting will be held at FDA’s main campus in Silver Spring, Maryland, on July 18, 2017, from 9:00 a.m. - 5:00 p.m. and will be webcast for those who cannot attend in person. Please submit electronic or written comments to Docket FDA-2017-N-3615 by September 18, 2017.
Notify Us
If you wish to attend in person or via webcast, or would like to present at the meeting, please email GenericDrugPolicy@fda.hhs.gov by July 3, 2017. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number, and whether you will be attending in person or by webcast). Those without email access can register by contacting Philip Bonforte (Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993, 240-402-6980) by July 3, 2017. If you need special accommodations because of a disability, please contact Philip Bonforte at least seven days before the meeting.

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