Computer Simulations Of Clinical Trials To Be Addressed In FDA Guidance
FDA plans to address the use of computer simulation models in an upcoming guidance on issues firms should consider at the end of Phase IIa
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FDA will not issue a final guidance on pharmacogenomic data submissions until later this year, Center for Drug Evaluation & Research Acting Director Steven Galson, MD, told the Biotechnology Industry Organization annual meeting in San Francisco June 8
FDA's "Critical Path" initiative will encourage drug manufacturers to use computer modeling to improve clinical trial design, Acting Deputy Commissioner for Operations Janet Woodcock, MD, said
FDA will begin a pilot program for end-of-Phase IIa meetings in advance of a draft guidance expected to be issued in early 2004