Human Research Subject Bill Unlikely In Next Four Years, Former Staffer Says
Executive Summary
Human research subject protection legislation is unlikely to move through Congress in the next several years, Paul Kim, food and drug counsel at Foley Hoag (Washington, D.C.), said
You may also be interested in...
Gregg Clinical Research Bill To Address Conflict Of Interest Without Caps
A bill to reform the human subject protection system under development by Sen. Judd Gregg (R-N.H.) will attempt to find a way to address potential conflict of interests without using caps on compensation
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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