What Does Rachel Sherman Think About Top FDA Regulatory Issues?
Speaking at the BIO CEO & Investor Conference, US agency's No. 2 official talks about compassionate use, opioids, clinical trial design, and the agency's succession plan.
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Sherman, who left the No. 2 post at FDA in January, is working part-time at Duke-Margolis and serving as a consultant to Medidata Solutions.
US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.
US FDA Principal Deputy Commissioner Rachel Sherman said during the BIO CEO & Investor conference that while investors and others would like to see complete response letters, the agency's hands are bound when it comes to their full release. Sherman also commented on FDA's focus for right-to-try legislation.