CAPLA sponsors should confer with CBER 12-18 months prior to filing -- CAPLA guidance.
Executive Summary
CAPLA SPONSOR SHOULD CONFER WITH CBER 12-18 MONTHS PRIOR TO SUBMISSION if its computerized application is designed for use on a network system. The Center for Biologics Evaluation & Research outlines an 18-month timeline for submissions in its "Computer Assisted Product License Application Guidance Manual" released March 21. The 12-18 month prior notice will assist the agency and the sponsor in determining whether the submission will require modification of CBER systems to accommodate the filing and "allow time for CBER to plan for the modification," the guidance states.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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