martes, 14 de marzo de 2017

FY 2017 Generic Drug Research Public Workshop / Extension of Comment Period for FDA Guidance “Considerations in Demonstrating Interchangeability With a Reference Product”

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
1. FY 2017 Generic Drug Research Public Workshop
FDA will be holding a public workshop on Wednesday, May 3, 2017 to obtain input from industry and other interested stakeholders on the identification of regulatory science priorities for FY 2018. The workshop will be held on May 3, 2017, at the FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Room 1503A (Great Room), Silver Spring, MD 20993. Additional information is posted in the Federal Register.
Comments regarding this public workshop may be submitted March 2, 2017 through June 2, 2017. If you wish to attend (either in person or by Webcast), please register by email to 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, and telephone number). This public workshop will include a public comment session. During online registration, you may indicate if you wish to present during the public comment session and which topic you wish to address. FDA will do its best to accommodate requests to make public comments. 
2. FDA extends comment period for the draft guidance “Considerations in Demonstrating Interchangeability With a Reference Product.”
The FDA has extended the comment period for the draft guidance for industry: “Considerations in Demonstrating Interchangeability With a Reference Product.” FDA originally published a notice with a 60-day comment period in the Federal Register of January 18, 2017. The Agency has received several requests for an extension of the comment period to allow sufficient time to develop a response to the notice. Therefore, FDA is extending the comment period for the notice for 60 days, until May 19, 2017. Please see the Federal Register Notice for information on how to submit comments to the docket.