[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Notices]
[Pages 22055-22056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8466]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-1540] (formerly Docket No. 99D-1540)


Guidance for Reviewers on Evaluating the Risks of Drug Exposure 
in Human Pregnancies; 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 reviewers entitled ``Reviewer Guidance: 
Evaluating the Risks of Drug Exposure in Human Pregnancies.'' This 
guidance is intended to help FDA staff evaluate human fetal outcome 
data generated after medical product exposures during pregnancy. The 
goal of such evaluations is to assist in the development of product 
labeling that is useful to medical care providers when they care for 
patients who are pregnant or planning pregnancy. The review of human 
pregnancy drug exposure data and assessment of fetal risk (or lack of 
risk) requires consideration of human embryology and teratology, 
pharmacology, obstetrics, and epidemiology. Consequently, FDA staff 
also are encouraged to consult with experts in these fields, as 
appropriate.
    The guidance announced in this document finalizes the draft 
guidance entitled ``Guidance for Reviewers: Evaluation of Human 
Pregnancy Outcome Data'' announced in the Federal Register of June 4, 
1999.

DATES: Submit written comments or electronic comments on agency 
guidances at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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 (CBER), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist either office in processing your requests. The guidance may also 
be obtained by mail by calling the CBER Voice Information System at 1-
800-835-4709 or 301-827-1800. Submit written comments on the guidance 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Dianne L. Kennedy, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5162, e-mail: 
[email protected], or Toni M. Stifano, Center for Biologics 
Evaluation and Research (HFM-602), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6190, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for reviewers 
entitled ``Reviewer Guidance: Evaluating the Risks of Drug Exposure in 
Human Pregnancies.'' The guidance provides FDA staff with critical 
factors to consider when evaluating data on the effects of drug 
exposure during human pregnancies. It also describes the sources of 
human data on gestational drug exposures and available resources for 
more information. The guidance is intended to provide FDA reviewers 
with a standardized and scientific approach to the evaluation of the 
effects of human gestational drug exposures.
    In the Federal Register of June 4, 1999 (64 FR 30040), FDA 
announced the availability of a draft version of the guidance entitled 
``Guidance for Reviewers: Evaluation of Human Pregnancy Outcome Data.'' 
When the draft guidance was published, FDA requested comments on the 
document. Three public comments were received. The comments were 
supportive of the agency's efforts to provide this type of guidance. 
However, the comments also recommended revision/clarification of 
several sections, as well as provided a number of suggestions of a more 
technical nature. Additionally, comments regarding the draft guidance 
raised the following three broader concerns: (1) That it contained 
redundant information already presented in the guidance for industry 
entitled ``Establishing Pregnancy Exposure Registries'' (draft: 64 FR

[[Page 22056]]

30040, June 4, 1999; final: 67 FR 59528, September 23, 2002), (2) that 
it focused too much on general epidemiologic issues, and (3) that it 
overemphasized the utility of pregnancy registries without a balanced 
review of the strengths of other data sources for evaluating pregnancy 
outcome data.
    Based on these comments and discussions with FDA's Pregnancy 
Labeling Subcommittee of the Advisory Committee for Reproductive Health 
Drugs on June 3, 1999 (64 FR 23340, April 30, 1999), and March 28 and 
29, 2000 (65 FR 10811, February 29, 2000), and with other interested 
parties, the draft guidance has been revised and finalized. The name 
has been changed from ``Evaluating Pregnancy Outcome Data'' to 
``Evaluating the Risks of Drug Exposure in Human Pregnancies'' to 
reflect more accurately the information contained in the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practice regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking with regard to evaluating data on the effects 
of drug exposure during pregnancy. 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 requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8466 Filed 4-27-05; 8:45 am]
BILLING CODE 4160-01-S