[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: 21CFR99.103]
[Page 448-449]
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. 99.103 Mandatory statements and information.
(a) Any information disseminated under this part shall include:
(1) A prominently displayed statement disclosing:
(i) For a drug, ``This information concerns a use that has not been
approved by the Food and Drug Administration.'' For devices, the
statement shall read, ``This information concerns a use that has not
been approved or cleared by the Food and Drug Administration.'' If the
information to be disseminated includes both an approved and unapproved
use or uses or a cleared and uncleared use or uses, the manufacturer
shall modify the statement to identify the unapproved or uncleared new
use or uses. The manufacturer shall permanently affix the statement to
the front of each reprint or copy of an article from a scientific or
medical journal and to the front of each reference publication
disseminated under this part;
(ii) If applicable, the information is being disseminated at the
expense of the manufacturer;
(iii) If applicable, the names of any authors of the information who
were employees of, or consultants to, or received compensation from the
manufacturer, or who had a significant financial interest in the
manufacturer during the time that the study that is the subject of the
dissemination was conducted up through 1 year after the time the
article/reference publication was written and published;
(iv) If applicable, a statement that there are products or
treatments that have been approved or cleared for the use that is the
subject of the information being disseminated; and
(v) The identification of any person that has provided funding for
the conduct of a study relating to the new use of a drug or device for
which such information is being disseminated; and
(2) The official labeling for the drug or device;
(3) A bibliography of other articles (that concern reports of
clinical investigations both supporting and not supporting the new use)
from a scientific reference publication or scientific or medical journal
that have been previously published about the new use of the drug or
device covered by the information that is being disseminated, unless the
disseminated information already includes such a bibliography; and
(4) Any additional information required by FDA under Sec.
99.301(a)(2). Such
[[Page 449]]
information shall be attached to the front of the disseminated
information or, if attached to the back of the disseminated information,
its presence shall be made known to the reader by a sticker or notation
on the front of the disseminated information and may consist of:
(i) Objective and scientifically sound information pertaining to the
safety or effectiveness of the new use of the drug or device and which
FDA determines is necessary to provide objectivity and balance. This may
include information that the manufacturer has submitted to FDA or, where
appropriate, a summary of such information and any other information
that can be made publicly available; and
(ii) An objective statement prepared by FDA, based on data or other
scientifically sound information, bearing on the safety or effectiveness
of the new use of the drug or device.
(b) Except as provided in paragraphs (a)(1)(i) and (a)(4) of this
section, the statements, bibliography, and other information required by
this section shall be attached to such disseminated information.
(c) For purposes of this section, factors to be considered in
determining whether a statement is ``prominently displayed'' may
include, but are not limited to, type size, font, layout, contrast,
graphic design, headlines, spacing, and any other technique to achieve
emphasis or notice. The required statements shall be outlined, boxed,
highlighted, or otherwise graphically designed and presented in a manner
that achieves emphasis or notice and is distinct from the other
information being disseminated.
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