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GUIDANCE DOCUMENT

Bioavailability Studies Submitted in NDAs or INDs – General Considerations February 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Submit Comments by 05/28/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-4367


Docket Number:
FDA-2018-D-4367
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Bioavailability Studies Submitted in NDAs or INDs—General Considerations.” This draft guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises and replaces FDA's March 2014 draft guidance for industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations,” which addresses BA or bioequivalence (BE) studies for INDs, NDAs, and NDA supplements.