In Brief: Regulatory reform proposal
Regulatory reform proposal: White House director of regulatory risk analysis would coordinate activities between FDA and six other federal agencies, under a proposal released March 20 by the Harvard Group on Risk Management Reform. Chaired by former Bush Administration Counsel C. Boyden Gray, the group also recommends increased local authorities, particularly "where the costs and benefits of risk management are incurred by citizens within a specific state or locality." Congress should also allow the feds flexibility to approve risk-management plans submitted by regulatees that would result in greater reduction of risk than would result from compliance with existing law...
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