FDA MEETINGS WITH PBM-OWNING MANUFACTURERS
FDA MEETINGS WITH PBM-OWNING MANUFACTURERS have included personnel drawn from the agency's offices of policy, management and systems, and general counsel in addition to representatives of the drag advertising review division. FDA attendees at separate meetings held in mid- to late-October with Merck, SmithKline Beecham, Pfizer and Lilly included top-level officials from across FDA's organizational structure: Deputy Commissioner/Senior Advisor to the Commissioner Mary Pendergast, Interim Deputy Commissioner for Operations Linda Suydam, Acting Deputy Commissioner for Policy William Hubbard, Center for Drug Evaluation & Research Director Janet Woodcock, MD, and General Counsel Margaret Porter.
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