Generic Manufacturers Urged To Take Lead On “Quality By Design”
Executive Summary
Generic companies may be in a better position to pioneer innovative "quality by design" manufacturing processes, G.K. Raju, PhD, executive director, Massachusetts Institute of Technology Pharmaceutical Manufacturing Initiative, says
You may also be interested in...
FDA “Quality By Design” Initially Focuses On Post-Approval Manufacturing
FDA will focus initially on the post-approval regulatory pathway as the most likely starting point for firms instituting "quality by design" manufacturing
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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