Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees

Description

This document provides guidance for industry on changes to the policies and procedures being used by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) with regard to advisory committees as a result of section 120 of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). This guidance document supplements the policies and procedures described in the Policy and Guidance Handbook for FDA Advisory Committees. In general, the guidance explains modifications, prompted by the Modernization Act, in CDER's and CBER's practices with regard to advisory committees.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR312.130§ 312.130 Availability for public disclosure of data and information in an IND.

  (a) The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.Read full regulation →

• 21CFR14.22§ 14.22 Meetings of an advisory committee.

  (a) No advisory committee may conduct a meeting except at the call or with the advance approval of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee.Read full regulation →

• 21CFR14.82§ 14.82 Nominations of voting members of standing advisory committees.

  (a) The Commissioner will publish one or more notices in the Federal Register each year requesting nominations for voting members of all existing standing advisory committees. The notice will invite the submission of nominations for voting members from both individuals and organizations.Read full regulation →

• 21CFR14.80§ 14.80 Qualifications for members of standing policy and technical advisory committees.

  (a) Members of a policy advisory committee—Read full regulation →

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