Today, FDA announced that it has decided to reopen, for 60 days, the comment period for certain parts of its controversial final guidance, “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND,” which was announced in the September 10, 2013 Federal Register. We blogged about the many problems we saw with this Final Guidance, and its approach to applying FDA’s drug IND regulations to foods. Perhaps, recognizing that it had overreached and failed to solicit comment on these critical issues before issuing the Final Guidance in September, FDA will now be accepting comments on those parts of the Final Guidance that addressed how FDA intended to apply the drug IND requirements in 21 C.F.R. Part 312 to clinical research studies involving cosmetics and foods (including dietary supplements).
FDA will publish a Federal Register notice announcing the reopening of the comment period.
If you have any questions or are interested in submitting comments to the agency, please let us know.