FDA moving forward

[timothy141]

Agenda: The committee will discuss new drug application (NDA) 204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by Gilead Sciences, Inc. (Nasdaq: GILD), with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

[Dee1956]

Very good news, thanks for sharing Timothy
Take care
D

[timothy141]

  

Looks like the FDA  is not going to drag its feet on this review of Sofosbuvir after all.

Yahoo! ( how does one yodel in print)

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Antiviral Drugs Advisory Committee.  General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues