Buckle Up For Brand Take Off: FDA's Checklist For Pilot Participants
FDA's proposed pilot to expedite proprietary name reviews would require sponsors to submit more comprehensive safety data, shifting the burden of testing look-a-like, sound-a-like names for medication errors. CDER and CBER recommend applicants submit the following information:
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