Description
This document provides guidance on how FDA interprets the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and 21 CFR 314.430 (§ 314.430) with respect to the disclosure of materials provided to advisory committees, and how FDA will exercise its discretion under § 314.430(d)(1)2 in connection with open advisory committee meetings convened by the Center for Drug Evaluation and Research (CDER) beginning on January 1, 2000.
Scope & Applicability
Stakeholders
3Decision maker in expedited withdrawal procedures; Provides opportunity for a meeting or written appeal during withdrawal procedures.; FDA Commissioner or their designee presiding over appeals
Entity submitting development data and knowledge; Entity performing the work process for change
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1Portions of data that may be disclosed for public consideration
Related CFR Sections (1)
- 21CFR314.430§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
(a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter . For purposes of this section, the application or abbreviated application includes all data and information submitted wRead full regulation →
See Also (8)
- Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry (Status: Final)
- Guidance for Industry 180-Day Exclusivity: Questions and Answers (Status: Draft)
- Competitive Generic Therapies (Status: Final)
- Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (Status: Final)
- Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (Status: Final)
- PDUFA Pilot Project: Proprietary Name Review - Concept Paper (Status: Final)
- Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry (Status: Draft)
- Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act (Status: Draft)