FDA SELF-REFORM PROPOSAL BEING DEVELOPED TO COUNTER OUTSIDE EFFORTS: KESSLER ASKS HILL FOR PATIENCE, SEVERAL MONTHS; PRIVATIZATION IDEAS WILL BE CONSIDERED
FDA is asking Capitol Hill for several months to work on its own internal plan for reform. Commissioner Kessler told Sen. Cochran's (R-Miss.) Appropriations/Agriculture Subcommittee at a March 1 hearing that FDA is "working with the Vice President in terms of regulatory reform, and I would hope in the next several months, Mr. Chairman, we could come back and make those suggestions to you." Cochran responded: "I hope you will."
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