FDA microbicide meeting
This article was originally published in The Tan Sheet
Executive Summary
Design of antimicrobial clinical trials will be discussed at an April 15-16 meeting sponsored by FDA and the Infectious Diseases Society of America, agency announces in Federal Register March 9. The public workshop will include input from interested groups on trial endpoints, drug development. Topics mirror those covered at a mid-2003 meeting of the FDA Antiviral Drugs Advisory Committee (1"The Tan Sheet" Aug. 25, 2003, p. 7). Meeting will take place at the Center for Drug Evaluation & Research, 5630 Fishers Lane, Rockville, Md...
|
Design of antimicrobial clinical trials will be discussed at an April 15-16 meeting sponsored by FDA and the Infectious Diseases Society of America, agency announces in Federal Register March 9. The public workshop will include input from interested groups on trial endpoints, drug development. Topics mirror those covered at a mid-2003 meeting of the FDA Antiviral Drugs Advisory Committee (1 (Also see "Microbicide Trial Three-Arm Design May Be Optimal Initially – Panelists" - Pink Sheet, 25 Aug, 2003.), p. 7). Meeting will take place at the Center for Drug Evaluation & Research, 5630 Fishers Lane, Rockville, Md.... |