Parallel track regulations
Executive Summary
National Institute of Allergy and Infectious Diseases' AIDS Research Advisory Committee emphasizes a "sincere desire for a definitive decision on the stalled parallel track initiative" in a Feb. 12 letter to NIAID Director Anthony Fauci, MD. The initiative would establish rules for NIAID's mechanism for expanded access to drugs still in clinical trials but has languished in the Office of Management and Budget for over a year. ARAC Chairman Gerald Medoff contended that parallel track "offers substantial improvements over the current ad hoc situation." The letter is expected to be sent to HHS' National AIDS Program Office.
You may also be interested in...
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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