BEBAC   Ing. Helmut Schütz

US – FDA

Draft Guidance for Industry: Bioavailability and Bio­equi­valence Studies Submitted in NDAs or INDs — General Considerations

On 18 Mar 2014 FDA’s Center for Drug Evaluation and Research (CDER) published the drafted guidance for a 60-day public consultation period (i.e., until 19 May 2014).

This guidance provides recommendations to sponsors and/or applicants planning to in­clude bioavailability (BA) and bioequivalence (BE) information for drug products in in­ves­tigational new drug applications (INDs), new drug applications (NDAs), and NDA supple­ments […]. This guidance contains advice on how to meet the BA and BE requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administra­tion. The guidance may also be applicable to non-orally administered drug products when reliance on systemic exposure measures is suitable to document BA and BE (e.g., trans­dermal delivery systems and certain rectal and nasal drug products). The guidance should be helpful for applicants conducting BA and BE studies during the IND period for an NDA and also for applicants conducting BE studies during the postapproval period for certain changes to drug products that are the subject of an NDA. This guidance document is not intended to provide recommendations on studies conducted in support of demonstrating comparability or biosimilarity for biological products licensed under section 351 of the Public Health Service Act.

When finalized, this guidance will revise and replace the parts of FDA’s March 2003 guid­ance for industry on Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations (the March 2003 BA and BE Guidance) relating to BA and BE studies for INDs, NDAs, and NDA supplements. Since the March 2003 BA and BE Guidance was issued, FDA has determined that providing information on BA and BE studies in separate guidances according to application type will be beneficial to sponsors and applicants. Thus, FDA is issuing this NDA BA and BE Draft Guidance and, as previ­ously noted, has issued the ANDA BE Draft Guidance for ANDA and ANDA supplements.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic comments on the draft guid­ance by May 19, 2014 to www.regulations.gov.
See also “Tips for Submitting Effective Comments”.

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