# Administrative Practices and Procedures; Internal Review of Decisions
> **Food and Drug Administration** · Final rule. · Published 1998-11-18 · Effective 1998-12-18 · 63 FR 63978
## Document
- **Document number:** 98-30812
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 63978
- **CFR reference:** 21 CFR 10
- **Publication date:** 1998-11-18
- **Effective date:** 1998-12-18
- **HHS docket:** Docket No. 98N-0361
## Abstract

The Food and Drug Administration (FDA) is amending the regulations governing the internal review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including human drugs, animal drugs, and human biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or advisory committee. This amendment implements the ``Dispute Resolution'' provision of the Food and Drug Administration Modernization Act (FDAMA). This document is intended to clarify that sponsors, applicants, or manufacturers of drugs, or devices may request review of scientific controversies by an appropriate scientific advisory panel or advisory committee.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/11/18/98-30812/administrative-practices-and-procedures-internal-review-of-decisions)
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