Conjugated estrogens bioequivalence standards to go before FDA advisory committees July 27-28.
Executive Summary
FDA CMTE. REVIEW OF CONJUGATED ESTROGENS INGREDIENTS SET FOR JULY 27-28 will involve the Fertility & Maternal Health Drugs Advisory Committee with representatives from the Generic Drugs and Endocrine & Metabolic Drugs committees. The panel will discuss "necessary components of conjugated estrogens and other estrogens as they relate to clinical efficacy of conjugated estrogens and other estrogen replacement drug products for approved indications," FDA said. The meeting will take place at FDA's Parklawn building, conference rooms D & E, at 9 a.m. each day.
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