martes, 14 de marzo de 2017

Invitation to attend and provide input: FDA’s FY 2018 Generic Drug Research Public Workshop

The Food and Drug Administration (FDA) is hosting the Generic Drug User Fee Amendments of 2012 (GDUFA) Regulatory Science Initiatives: Request for Public Input for FY 2018 Generic Drug Research Public Workshop to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the fiscal year (FY) 2017 research priorities.
FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public workshop into account in developing the FY 2018 Regulatory Science Plan.
Participate
The meeting will be held at FDA’s main campus in Silver Spring, Maryland, on May 3, 2017, from 8:30am-4:30pm and will be a webcast for those who cannot attend in person.
Please submit electronic or written requests to make oral presentations and comments by April 5, 2017. You may suggest generic drug research topics that should be added to the FY 2018 Regulatory Science Plan by submitting electronic or written comments to Docket FDA– 2013–N–0402 30 days prior and 60 days after the workshop date.

Notify Us
If you wish to attend in person or via webcast, or would like to present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov by April 5, 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 Stephanie Choi (Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 75, Rm 4736, Silver Spring, MD 20993, 240-402-7960) by April 5, 2017. If you need special accommodations because of a disability, please contact Stephanie Choi at least seven days before the hearing.