FDA Webview
X

Free FDA Notices

Panel to Discuss Gene Therapy Guidance

08/25/2014

Federal Register Notice: FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/6 from 9 a.m. to about 4:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss the draft guidance for industry entitled Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products and the Dear Gene Therapy IND or Master File Sponsor Letter. Contact Gail Dapolito or Rosanna Harvey, (240) 402-8046 or (240) 402-8072, email: Gail.Dapolito@fda.hhs.gov or Roasanna.Harvey@fda.hhs.gov. To view this notice, click here.

LATEST NEWS