2005D-0183 Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
FDA Comment Number : EC3
Submitter : Dr. Lynn Smiley Date & Time: 07/28/2005 06:07:53
Organization : Trimeris, Inc
Category : Drug Industry
Issue Areas/Comments
GENERAL
GENERAL
Reference is made to Docket No. 2005D - 0183, as published by the Food and Drug Administration in the Federal Register on May 25, 2005, to invite written comments on a new draft guidance for industry 'Conducting Virology Studies and Submitting the Data to the Agency; Availability'. The purpose of this e-mail is to provide comments from Trimeris, a biopharmaceutical company focused on developing HIV fusion inhibitors, on this new draft guidance - see attachment.




2005D-0183-EC3-Attach-1.DOC