FDA user fee hearing
Rep. Waxman's (D-Calif.) Energy & Commerce/health subcommittee hearing on FDA user fees is tentatively scheduled for Aug. 10. FDA Commissioner Kessler has been scrambling to build a consensus on user fee legislation and recently stepped up agency dialog with PMA and key congressional staffers in a series of meetings in July ("The Pink Sheet" July 20, T&G-8). On July 29, Kessler and CDER Director Carl Peck met with Waxman staffer Bill Schultz for the second time in three weeks. House and Senate staffers are hoping to craft a bill that can win PMA support before the end of the current session of Congress....
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