STABILITY DEFICIENCIES HEAD LIST OF REASONS FOR ANDA/AADA REFUSE-TO-FILE
Executive Summary
STABILITY DEFICIENCIES HEAD LIST OF REASONS FOR ANDA/AADA REFUSE-TO-FILE actions by FDA, Office of Generic Drugs Operations Research Analyst Eileen Nolan told the National Association of Pharmaceutical Manufacturers mid-year meeting in Washington, D.C. June 15. According to the survey, which was conducted to satisfy requirements mandated by the HHS Inspector General, stability difficulties appeared 20% of the time; raw materials deficiencies 18.4%; and analytical problems 14.5%, Nolan reported.
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