SIMULTANEOUS SUBMISSION OF GENE THERAPY PROTOCOLS TO FDA, NIH ON RAC AGENDA
The simultaneous submission of protocols for gene therapy treatments to FDA and the National Institutes of Health will be considered by the NIH Recombinant DNA Advisory Committee as part of proposed consolidated review procedures at its March 6-7 meeting in Bethesda, Md.
You may also be interested in...
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
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth