FDA Issues Draft Guidance on Bioavailability and Bioequivalance Studies

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-26-2014 09:23


FDA has issued draft guidance, Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs: General Considerations. The 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new drug applications (INDs), new drug applications (NDAs), and NDA supplements (referred to as the NDA BA and BE Draft Guidance).This guidance contains advice on how to meet the BA and BE requirements set forth in 21 CFR Part 320 as they apply to dosage forms intended for oral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. 

FDA said that 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according to application type will be beneficial to sponsors and applicants Thus, FDA is issuing this NDA BA and BE Draft Guidance and, as previously noted, has issued the ANDA BE Draft Guidance for ANDA and ANDA supplements.

Source: FDA



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