PROCESS VALIDATION IS NOT PROPER TIME TO CONFIRM ACCURACY OF SPECS
Executive Summary
PROCESS VALIDATION IS NOT PROPER TIME TO CONFIRM ACCURACY OF SPECS, FDA Newark District Pre-Approval Program Director Heather Pedersen told attendees of an NAPM/NPA workshop May 3. Speaking at the National Association of Pharmaceutical Manufacturers and National Pharmaceutical Association's "Vital Signs for Successful Validation" conference in Newark, Pedersen said generic firms often try to "tweak" product specification in the validation stage because they are not predetermined in development, reducing the integrity of the validation process itself.
You may also be interested in...
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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