FDA DIVISION OF GENERIC DRUGS' DOCUMENT ROOM WILL BE HANDLED BY OUTSIDE CONTRACTOR, ZIMMERMAN ASSOCIATES; GENERIC REVIEW POLICY CHANGES RECAPPED
FDA's Division of Generic Drugs is turning over the handling of document room services to an outside contractor, Zimmerman Associates, beginning June 4. Office of Generic Drugs Acting Director Bruce Burlington informed division staff in a May 30 memorandum that the company would be entering data, identifying, processing, tracking and distributing documents. The move to an outside contractor is the latest in a series of agency efforts designed to ensure the integrity of the generic drug review process. Burlington's memo notes that access to the document room will be limited during work hours to those with an FDA identification badge and during other hours to "personnel with security zone clearance." Many of the housecleaning changes in FDA's generic review operations have been effected through a series of almost two dozen policy and procedure guidances for agency staff (see chart). Center for Drug Evaluation and Research Director Carl Peck made the agency's first formal announcement of the availability of the guides in a June 1 letter to all NDA and ANDA holders and applicants. "These guides should provide you insight into FDA's efforts to devise new policies and procedures that attempt to assure fair, and even-handed dealings with applicants," Peck said, noting that FDA will continue to issue guides.
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