# Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2016-03-28 · Effective 2016-03-28 · 81 FR 17065
## Document
- **Document number:** 2016-06886
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 17065
- **CFR reference:** 21 CFR 312
- **Publication date:** 2016-03-28
- **Effective date:** 2016-03-28
- **HHS docket:** Docket No. FDA-2016-N-0011
## Abstract

The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/03/28/2016-06886/investigational-new-drug-applications-for-biological-products-bioequivalence-regulations-technical)
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