Zdrowie i gospodarka · 06/07/2012

FDA Requests Public Comment on Enhanced Review Transparency and Communication Program for New Molecular Entity and Biologics Applications

The FDA is seeking public comment on a program aimed at increasing transparency and communication for new molecular entity and biologics applications, as part of the Prescription Drug User Fee Act V. The program will be evaluated by an independent contractor and is part of the FDA's performance commitments under the proposed law.