BARR LABS OUT-OF-SPEC TEST RESULTS FOR ALL REINTRODUCED PRODUCTS MUST BE REPORTED TO FDA FOR TWO YEARS AFTER VALIDATION APPROVAL, CONSENT ORDER DECREES
Executive Summary
Barr Labs is required to inform FDA of every out-of- specification test result concerning any previously suspended product for which the company has received agency approval to reintroduce, according to a Nov. 7 consent order issued by Newark, N.J. federal court Judge Alfred Wolin.
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