In Brief: U.S.-EU GMP Mutual Recognition
U.S.-EU GMP Mutual Recognition: Negotiations are expected to recommence the week of Jan. 27 in Washington, D.C., after stumbling early in the month when the EU Commission expressed reservations about exchanging inspection reports under any MRA. The EU also called for shortening the equivalency determination period from 3 years to 18 months. Negotiators had believed a compromise was reached at a Chicago meeting of the Trans-Atlantic Business Dialogue Nov. 8-9, and had vowed to complete an MRA by the end of January ("The Pink Sheet," Nov. 18, 1996, T&G-13)...
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