NIH/INDUSTRY PRICING FORMULA AGREEMENT MAY BE PREREQUISITE TO CRADA PRODUCT LAUNCH UNDER REVISED WYDEN BILL; PASSAGE THIS YEAR NOT LIKELY, AIDE SAYS
An agreement with the National Institutes of Health on pricing would be a prerequisite for a company to launch a product developed through a Cooperative Research & Development Agreement with NIH under a revised version of CRADA legislation being developed by Rep. Wyden (D-Ore.), Wyden Chief Health Policy Advisor David Schulke told the Drug Information Association annual meeting June 8.
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