Clinical Trial Regs: FDA Seeks Advice On How To Make Them Better, Faster, Stronger
FDA is holding a two-day public hearing to get input on how to modernize its regulation of clinical trials; stakeholders cite need for innovative trial design, data sharing, guidance on use of biomarkers.
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The agency estimates that 88 sponsors will develop approximately 132 monitoring plans annually, as recommended in FDA’s draft guidance on oversight of clinical investigations; CDER will not be conducting prospective reviews of these plans but may do a pilot program in the future.
Recent Duke University survey found that firms predominately conduct frequent visits to each clinical investigator site but "the rationale behind any specific monitoring approach does not appear to be evidence-based."
Sponsors will have to provide new information to FDA under the agency’s final rule on investigational new drug safety reporting requirements.