[Federal Register: May 19, 2000 (Volume 65, Number 98)]
[Notices]
[Page 31916-31917]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my00-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1278]


Draft Guidance for Industry on Female Sexual Dysfunction:
Clinical Development of Drug Products for Treatment; 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availability of a draft guidance for industry entitled ``Female Sexual
Dysfunction: Clinical Development of Drug Products for Treatment.'' The
draft guidance is intended to provide recommendations to industry on
the development of drug products for the treatment of female sexual
dysfunction (FSD).

DATES: Submit written comments on the draft guidance by July 18, 2000.
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Copies of this draft guidance for industry can be obtained
on the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit
written requests for single copies of the draft guidance to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your requests. Submit written comments on the draft guidance
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lana L. Pauls, Center for Drug
Evaluation and Research (HFD-580), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4260.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Female Sexual Dysfunction:
Clinical Development of Drug Products for Treatment.'' The draft
guidance provides recommendations for sponsors designing clinical
trials in support of new drug applications for the treatment of FSD. It
includes recommendations on the appropriate definition of the patient
population to be studied, inclusion and exclusion criteria, the use of
scales and questionnaires to assess FSD, and

[[Page 31917]]

primary endpoints for trials of drug products.
    This Level 1 draft guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). The draft
guidance represents the agency's current thinking on the development of
drugs for the treatment of FSD. 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 submit to the Dockets Management Branch
(address above) written comments on the draft guidance. 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 draft guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 12, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-12594 Filed 5-18-00; 8:45 am]
BILLING CODE 4160-01-F