21 U.S.C. § 356b : US Code - Section 356B: Reports of postmarketing studies

Search 21 U.S.C. § 356b : US Code - Section 356B: Reports of postmarketing studies

(a) Submission
(1) In general
A sponsor of a drug that has entered into an agreement with the
Secretary to conduct a postmarketing study of a drug shall submit
to the Secretary, within 1 year after the approval of such drug
and annually thereafter until the study is completed or
terminated, a report of the progress of the study or the reasons
for the failure of the sponsor to conduct the study. The report
shall be submitted in such form as is prescribed by the Secretary
in regulations issued by the Secretary.
(2) Agreements prior to effective date
Any agreement entered into between the Secretary and a sponsor
of a drug, prior to November 21, 1997, to conduct a postmarketing
study of a drug shall be subject to the requirements of paragraph
(1). An initial report for such an agreement shall be submitted
within 6 months after the date of the issuance of the regulations
under paragraph (1).
(b) Consideration of information as public information
Any information pertaining to a report described in subsection
(a) of this section shall be considered to be public information to
the extent that the information is necessary -
(1) to identify the sponsor; and
(2) to establish the status of a study described in subsection
(a) of this section and the reasons, if any, for any failure to
carry out the study.
(c) Status of studies and reports
The Secretary shall annually develop and publish in the Federal
Register a report that provides information on the status of the
postmarketing studies -
(1) that sponsors have entered into agreements to conduct; and
(2) for which reports have been submitted under subsection
(a)(1) of this section.
(d) Disclosure
If a sponsor fails to complete an agreed upon study required by
this section by its original or otherwise negotiated deadline, the
Secretary shall publish a statement on the Internet site of the
Food and Drug Administration stating that the study was not
completed and, if the reasons for such failure to complete the
study were not satisfactory to the Secretary, a statement that such
reasons were not satisfactory to the Secretary.
(e) Notification
With respect to studies of the type required under section
356(b)(2)(A) of this title or under section 314.510 or 601.41 of
title 21, Code of Federal Regulations, as each of such sections was
in effect on the day before the effective date of this subsection,
the Secretary may require that a sponsor who, for reasons not
satisfactory to the Secretary, fails to complete by its deadline a
study under any of such sections of such type for a drug or
biological product (including such a study conducted after such
effective date) notify practitioners who prescribe such drug or
biological product of the failure to complete such study and the
questions of clinical benefit, and, where appropriate, questions of
safety, that remain unanswered as a result of the failure to
complete such study. Nothing in this subsection shall be construed
as altering the requirements of the types of studies required under
section 356(b)(2)(A) of this title or under section 314.510 or
601.41 of title 21, Code of Federal Regulations, as so in effect,
or as prohibiting the Secretary from modifying such sections of
title 21 of such Code to provide for studies in addition to those
of such type.