Combo vaccine PLAs may be based on component efficacy trials plus bridging data -- FDA guidance.
COMBINATION VACCINE PLAs MAY REFERENCE STUDY DATA FROM LICENSED COMPONENTS in support of approval, if the components "have been licensed based upon well-controlled studies of protective efficacy," according to FDA's "Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies." The guidance document was announced in the April 10 Federal Register. The agency will accept comments on the guidance.
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