Generic Polymorph Screens Should Occur Early, Advisory Committee Says
Executive Summary
Generic companies should screen for polymorphs early in the development process, FDA's Pharmaceutical Science Advisory Committee suggested
You may also be interested in...
FDA Patent Listing Criteria Allow Polymorph, Product-By-Process Claims
FDA's proposed reforms to the Orange Book patent listing procedures would allow companies to list patents covering polymorphs and some types of manufacturing processes
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