Gene Therapy Trial Monitors Must Not Report To Sponsor-Investigators - Cmte
Clinical monitors for gene therapy trials must be independent from sponsor-investigators, FDA's Biological Response Modifiers Advisory Committee concluded April 5.
You may also be interested in...
Manufacturing quality assurance documentation could become a key component of gene therapy IND submissions, FDA Cellular & Gene Therapies Division Director Philip Noguchi, MD, suggested April 5.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011