[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.171]
[Page 161.162]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
Subpart I Advisory Committees for Human Prescription Drugs
Sec. 14.171 Utilization of an advisory committee on the initiative of FDA.
(a) Any matter involving a human prescription drug under review
within the agency may, in the discretion of the Commissioner, be the
subject of a public hearing and continuing or periodic review by the
appropriate standing technical advisory committee for
[[Page 162]]
human prescription drugs. The Commissioner's determinations on the
agenda of the committee are based upon the priorities of the various
matters pending before the agency which fall within the pharmacologic
class covered by that committee.
(b) High priority for such hearing and review by the appropriate
standing technical advisory committee for human prescription drugs are
given to the following types of human prescription drugs:
(1) Investigational drugs which are potential therapeutic advances
over currently marketed products from the standpoint of safety or
effectiveness, or which pose significant safety hazards, or which
present narrow benefit-risk considerations requiring a close judgmental
decision on approval for marketing, or which have a novel delivery
system or formulation, or which are the subject of major scientific or
public controversy, or which may be subject to special regulatory
requirements such as a limitation on clinical trials, a patient followup
requirement, postmarketing Phase IV studies, distributional controls, or
boxed warnings.
(2) Marketed drugs for which an important new use has been
discovered or which pose newly discovered safety hazards, or which are
the subject of major scientific or public controversy, or which may be
subject to important regulatory actions such as withdrawal of approval
for marketing, boxed warnings, distributional controls, or newly
required scientific studies.
(c) The committee may request the Commissioner for an opportunity to
hold a public hearing and to review any matter involving a human
prescription drug which falls within the pharmacologic class covered by
the committee. The Commissioner may, after consulting with the
committtee on such request, grant or deny the request in light of the
priorities of the other matters pending before the committee. Whenever
feasible, consistent with the other work of the committee, the request
will be granted.
(d) For a drug that meets any of the criteria established in
paragraph (b) of this section, one or more members of or consultants to
the appropriate advisory committee may be selected for more detailed
monitoring of the matter and consultation with FDA on behalf of the
committee. The member or consultant may be invited to attend appropriate
meetings and shall assist the center in any briefing of the committee on
that matter.
(e) An advisory committee may obtain advice and recommendations from
other agency advisory committees, consultants, and experts which the
advisory committee and the center conclude would facilitate the work of
the advisory committee.
(f) Presentation of all relevant information about the matter will
be made in open session unless it relates to an IND the existence of
which has not previously been disclosed to the public as defined in
Sec. 20.81 or is otherwise prohibited from public disclosure under part
20 and the regulations referenced therein. Sections 314.430 and 601.51
determine whether, and the extent to which, relevant information may be
made available for public disclosure, summarized and discussed in open
session but not otherwise made available for public disclosure, or not
in any way discussed or disclosed in open session or otherwise disclosed
to the public.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]
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