Generic company receives FDA warning letter Aug. 28 regarding tamper resistant packaging, including a failure to describe TRP features in product labeling, tape seals that can be defeated without detection, and a lack of appropriate information on blister packs of capsules. Pennex says it has responded to the letter and that it is changing labeling and TRP to come into compliance. . . .
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