CDER/ORA improved communication pilot
FDA's Office of Generic Drugs, Office of Compliance and Office of Regulatory affairs have successfully completed a pilot effort to improve communications between reviewers and field staff, an area that received criticism during the generic drug investigations. In the pilot effort, an ANDA reviewer accompanied an FDA field investigator during a preapproval inspection for Sterling's lidocaine 2%, and addressed problems in the application, which was approved on Feb. 26, on site. FDA said that results of the program were "positive" and the agency is assessing "the costs and benefits of applying such an approach on a broader basis".
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