[Federal Register Volume 62, Number 166 (Wednesday, August 27, 1997)]
[Notices]
[Pages 45425-45426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0345]
Guidance for Industry on Postmarketing Adverse Experience
Reporting for Human Drug and Licensed Biological Products:
Clarification of What to Report; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Postmarketing
Adverse Experience Reporting for Human Drug and Licensed Biological
Products: Clarification of What to Report.'' The purpose of this
guidance document is to clarify requirements for postmarketing safety
reporting. This guidance document is intended to improve the quality of
safety reports submitted to FDA while streamlining the postmarketing
surveillance of human drug and licensed biological products.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the guidance
for industry ``Postmarketing Adverse Experience Reporting for Human
Drug and Licensed Biological Products: Clarification of What to
Report'' to the
[[Page 45426]]
Drug Information Branch (HFD-210), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, or the Office of Communication, Training and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.
Send one self-addressed adhesive label to assist the office in
processing your requests. Submit written comments on the guidance
document to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
For information concerning human drug products: Audrey A. Thomas,
Center for Drug Evaluation and Research (HFD-7), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5625.
For information concerning human licensed biological products:
Marcel E. Salive, Center for Biologics Evaluation and Research (HFM-
220), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852-1448, 301-827-3974.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Postmarketing Adverse Experience
Reporting for Human Drug and Licensed Biological Products:
Clarification of What to Report.'' FDA has undertaken a major effort to
clarify and revise its regulations regarding pre- and postmarketing
safety reporting requirements for human drug and biological products.
With regard to the postmarketing safety reporting regulations for human
drug and licensed biological products, the agency published a proposed
rule in the Federal Register of October 27, 1994 (59 FR 54046), to
amend these requirements, as well as others, to implement international
standards, and to facilitate the reporting of adverse experiences. FDA
is still considering comments submitted in response to this proposed
rule and will be finalizing the proposed amendments based on those
comments as well as on recommendations developed by the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH) and by the World Health
Organization's Council for International Organizations of Medical
Sciences (CIOMS). In addition, in response to the President's
regulatory reinvention initiative, which directed departments and
agencies to eliminate or modify regulations that are outdated or
otherwise in need of reform, FDA recently published a final rule in the
Federal Register (62 FR 34166, June 25, 1997) that revokes the
postmarketing safety reporting requirement to submit expedited
increased frequency reports for human drug and licensed biological
products.
At this time, the agency is considering recommendations recently
developed by ICH and plans to propose additional amendments to its
postmarketing safety reporting regulations. Throughout this effort, the
agency intends to develop guidances for industry to provide
recommendations on how industry can best fulfill the postmarketing
safety reporting requirements. FDA plans to prepare a single
consolidated guidance document on this topic once the process is
concluded.
This guidance document: (1) Describes the information that should
be obtained before an individual case of an adverse experience should
be considered for submission to FDA in an expedited or periodic report;
(2) clarifies how safety information from solicited contacts with
patients should be handled; and (3) informs applicants and licensed
manufacturers that FDA will entertain waiver requests for periodic
submission of individual case reports for adverse experiences that are
determined to be nonserious and labeled. The guidance for industry
should be used in conjunction with CDER's ``Guideline for Postmarketing
Reporting of Adverse Drug Experiences'' (March 1992) and CBER's
``Guideline for Adverse Experience Reporting for Licensed Biological
Products'' (October 1993).
This guidance document represents the agency's current thinking on
reporting of certain postmarketing adverse experiences for human drug
and licensed biological products. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirement of the applicable statute, regulations, or both.
Interested persons may, at any time, submit written comments and
requests on the guidance document to the Dockets Management Branch
(address above). Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The guidance document and received comments may be seen in
the office above between 9 a.m. and 4 p.m., Monday through Friday.
An electronic version of this guidance is also available on the
Internet at http://www.fda.gov/cder/guidance.htm or http://www.fda.gov/
cber/guidelines.htm.
Dated: August 21, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-22790 Filed 8-26-97; 8:45 am]
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