Sponsor-FDA Communications In IND Phase Will Get Outside Review
US FDA seeks White House approval for to contract for interviews with 100 to 150 active commercial IND holders.
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'Polarization of opinions has always been a problem for us and has only been heightened,' CDER chief tells DIA.
Structured assessments, which are currently publicly available only for approved products, could help frame questions for panel discussion of specific drugs under review; FDA also exploring ways to make completed frameworks more readily accessible.
Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.