FDA's PROPOSED IND REPORTING REQUIREMENTS SHOULD BE LIMITED TO POTENTIALLY TOXIC DRUGS OR NOVEL NEW ENTITIES, FIRMS SAY; RESEARCH MAY BE AFFECTED
FDA's proposal to increase reporting requirements for investigational new drugs should apply only to drugs that are novel or are a potential safety risk, a number of companies suggested in comments to FDA. The comment period on FDA's Oct. 27 proposed rule ended Jan. 25.
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