STABILITY DEFICIENCIES HEAD LIST OF REASONS FOR ANDA/AADA REFUSE-TO-FILE
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...
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 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
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