Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here). This 42‑page guidance supersedes the December 2013 draft guidance of the same name. The document provides updated recommendations and the FDA’s current thinking on the general concepts for providing bioequivalence data to support an ANDA for oral drug products and non-oral products that are systemically absorbed and upon which systemic exposure is deemed suitable for determining bioequivalence.
“In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations” as noted in the Federal Register Notice announcing the availability of the draft guidance (here). “FDA received nine comments on the draft guidance, which were considered before publication of this revised draft guidance,” and that are addressed in the guidance. The guidance incorporates other revisions based on the experience that the FDA has gained over the eight years since the 2013 draft guidance was issued, and may answer some of the questions that were posed in controlled correspondence over the course of time.
On another front, the FDA also announced, in the FR prepublication page (here), the issuance of twenty‑three new and fourteen revised Product-Specific Guidances (PSGs). The new and revised guidances can be found here. Some of the revisions have been revised multiple times; for instance, Ferric Citrate Tablets has been revised three times.
All in all, lots of new and revised information was published today. Hopefully, the Guidance and the PSGs won’t come too late to incorporate changes into product testing plans for ANDA submissions for those firms doing so.
