FDA Adverse Event Database Study Grant Specifies 15 NMEs To Track
Bristol-Myers Squibb's oral anti-diabetic Glucophage is one of 15 new molecular entities FDA would like to track through its fiscal 1999 cooperative grant program for use of pharmacoepidemiological databases linked to medical records, the agency said in a June 19 Federal Register notice announcing the $1.4 mil. program.
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