FDA's "SMART" STRATEGIC PLAN FIRST VERSION NEARING COMPLETION; ELECTRONIC FILE MANAGEMENT PROJECT ALSO TOP PRIORITY AT CDER, DIRECTOR WOODCOCK SAYS
A first draft of a strategic plan for FDA's Submission Management and Review Tracking system is expected to be completed within the next few weeks, Systems Research & Applications Corp. Program Manager Sherman Greenstein announced at an Oct. 31-Nov. 2 meeting on Computer-Assisted New Drug Development and Review sponsored by the Pharmaceutical Research & Manufacturers of America and FDA in Washington, D.C.
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