|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|
| 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by the Food and Drug Administration in the Federal Register on May 25, 2005, to invite written comments on a new draft guidance for industry 'Conducting Virology Studies and Submitting the Data to the Agency; Availability'.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to provide comments from Trimeris, a biopharmaceutical company focused on developing HIV fusion inhibitors, on this new draft guidance - see attachment.