FDA Science Board Will Look At “Future Plans” For “Critical Path” At Nov. 5 Meeting
This article was originally published in The Pink Sheet Daily
The meeting is one of several by the agency to discuss the drug development initiative. The final report of FDA’s good manufacturing practices initiative will also be reviewed.
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FDA will also offer a revised bio-inequivalence proposal at an Oct. 20 Pharmaceutical Science Advisory Committee meeting. On Oct. 19, the committee will discuss FDA's Critical Path initiative, risk-based GMP progress and parametric interval testing.
FDA will consider defining the procedures for requesting "pre-pre-IND" meetings, the agency said at a public workshop on facilitating biologics development Oct. 7
A task force will hear input on what steps HHS can take to create or enhance coordination across agencies to stimulate the development of new drug, biological and medical device products. The task force’s report is expected to be released by year-end.