[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: 21CFR99.101]
[Page 447-448]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED
Subpart B Information To Be Disseminated
Sec. 99.101 Information that may be disseminated.
(a) A manufacturer may disseminate written information concerning
the safety, effectiveness, or benefit of a use not described in the
approved labeling for an approved drug or device or in the statement of
intended use for a cleared device, provided that the manufacturer
complies with all other relevant requirements under this part. Such
information shall:
(1) Be about a drug or device that has been approved, licensed, or
cleared for marketing by FDA;
(2) Be in the form of:
(i) An unabridged reprint or copy of an article, peer-reviewed by
experts qualified by scientific training or experience to evaluate the
safety or effectiveness of the drug or device involved, which was
published in a scientific or medical journal. In addition, the article
must be about a clinical investigation with respect to the drug or
device and must be considered to be scientifically sound by the experts
described in this paragraph; or
(ii) An unabridged reference publication that includes information
about a clinical investigation with respect to the drug or device, which
experts qualified by scientific training or experience to evaluate the
safety or effectiveness of the drug or device that is the subject of the
clinical investigation would consider to be scientifically sound;
(3) Not pose a significant risk to the public health;
[[Page 448]]
(4) Not be false or misleading. FDA may consider information
disseminated under this part to be false or misleading if, among other
things, the information includes only favorable publications when
unfavorable publications exist or excludes articles, reference
publications, or other information required under Sec. 99.103(a)(4) or
the information presents conclusions that clearly cannot be supported by
the results of the study; and
(5) Not be derived from clinical research conducted by another
manufacturer unless the manufacturer disseminating the information has
the permission of such other manufacturer to make the dissemination.
(b) For purposes of this part:
(1) FDA will find that all journal articles and reference
publications (as those terms are defined in Sec. 99.3) are
scientifically sound except:
(i) Letters to the editor;
(ii) Abstracts of a publication;
(iii) Those regarding Phase 1 trials in healthy people;
(iv) Flagged reference publications that contain little or no
substantive discussion of the relevant clinical investigation; and
(v) Those regarding observations in four or fewer people that do not
reflect any systematic attempt to collect data, unless the manufacturer
demonstrates to FDA that such reports could help guide a physician in
his/her medical practice.
(2) A reprint or copy of an article or reference publication is
``unabridged'' only if it retains the same appearance, form, format,
content, or configuration as the original article or publication. Such
reprint, copy of an article, or reference publication shall not be
disseminated with any information that is promotional in nature. A
manufacturer may cite a particular discussion about a new use in a
reference publication in the explanatory or other information attached
to or otherwise accompanying the reference publication under Sec.
99.103.
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