# Investigational New Drug Applications; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2009-10-29 · Effective 2009-10-29 · 74 FR 55770
## Document
- **Document number:** E9-26095
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 55770
- **CFR reference:** 21 CFR 312
- **Publication date:** 2009-10-29
- **Effective date:** 2009-10-29
- **HHS docket:** Docket No. FDA-2009-N-0464
## Abstract

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/10/29/E9-26095/investigational-new-drug-applications-technical-amendment)
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