Animal Rule's Effect On Anthrax Vaccines To Be Discussed By Advisory Committee
This article was originally published in The Pink Sheet Daily
Executive Summary
Companies seeking approval for post-exposure prophylaxis will present their study designs in closed session.
You may also be interested in...
Gardasil Anal Cancer Indication To Face FDA Advisory Committee Scrutiny
Supplemental application filed earlier this year is part of Merck's strategy to broaden use of the HPV vaccine, although its bid to expand the label to women ages 27-45 has thus far been blocked by the agency.
FDA Moving Beyond Animal Rule To Animal Guidance With November Workshop
Focus will be on addressing regulatory challenges faced in developing countermeasures to chemical, biological and radiological threats.
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.