NDMA on good manufacturing practices
In June 14 comments to FDA on its Feb. 12 proposal to change certain CGMP requirements for finished drugs, the Nonprescription Drug Manufacturers Association recommended that FDA drop the requirement for annual examination of reserve samples for evidence of deterioration. NDMA argues that other methods such as stability studies, shelf-life studies, and complaint investigations can provide adequate stability information on products.
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