FDA – Page 55 – Policy & Medicine

FDA to Consider Accelerated Approval for Special Medical Use

FDA to Study Disease Awareness Programs

FDA Prescription Drug Marketing Regulatory Primer

Biosimilar Price Competition and Innovation Act – Discussions on the Biosimilar Pathway

CBI 14th Annual Forum on Off-Label Guidelines

FDA Generic Drug User Fee Act Draft Guidance

FDA Goals for the Center for Drug Evaluation and Research CDER for FDASIA

Prescription Drug Shortages: FDA Clarifies Congressional Report

FDA Seeks Comments on Transparency and Communication for New Entities

FDA: Recently Signed PDUFA 5 Provisions to Address Drug Shortages