[Federal Register Volume 60, Number 23 (Friday, February 3, 1995)]
[Notices]
[Pages 6713-6714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2630]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0004]
Vaginal Contraceptive Drug Products; Guidance on Content of New
Drug Applications; 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 document for manufacturers of vaginal
contraceptive drug products entitled, ``Guidance for Development of
Vaginal Contraceptive Drugs.'' This guidance document is intended to
facilitate the development of data in support of new drug applications
(NDA's), which FDA has proposed to require for all over-the-counter
(OTC) vaginal contraceptives.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance for Development of Vaginal Contraceptive
Drugs'' to the Division of Metabolism and Endocrine Drug Products (HFD-
510), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857. Requests should
be identified with the docket number found in brackets in the heading
of this document. Send two self-addressed adhesive labels to assist
that office in processing your requests. The guidance document is
available for public examination in the Dockets Management Branch (HFA-
305), Food and Drug Administration, Rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Lisa Stockbridge, Center for Drug
Evaluation and Research (HFD-510), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-3520.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance document entitled ``Guidance for Development of Vaginal
Contraceptive Drugs'' on content of NDA's for manufacturers of vaginal
contraceptive drug products. As part of FDA's ongoing review of OTC
drug products, the agency is publishing elsewhere in this issue of the
Federal Register a proposed rule that addresses OTC vaginal
contraceptive drug products. The preamble to that proposed rule sets
forth FDA's determination that the effectiveness of OTC vaginal
contraceptives is highly variable and is dependent on final
formulation. Because in vitro testing does not adequately predict the
effectiveness of these products, FDA is proposing to call for the
submission of product-specific marketing applications for vaginal
contraceptives, including effectiveness data obtained from clinical
studies of the products in their final formulations.
The guidance document is intended to assist manufacturers in the
preparation of NDA's for vaginal contraceptive drug products. It
describes the chemistry, pharmacology, [[Page 6714]] biopharmaceutic,
and clinical information required in support of these applications for
vaginal contraceptive drug products.
Like other guidance issued by FDA, this document states practices
or procedures that may be useful, but are not legal requirements. Such
guidance represents the agency's position at the time of issuance. A
person may follow the guidance or may choose to follow alternate
practices or procedures. If a person chooses to use alternate practices
or procedures, that person may wish to discuss the matter further with
the agency to prevent an expenditure of money and effort on activities
that may later be determined to be unacceptable to FDA.
A guidance such as this does not bind FDA, and it does not create
or confer any rights, privileges, or benefits for or on any person.
When a guidance states a requirement imposed by statute or regulation,
however, the requirement is law, and its force and effect are not
changed in any way by virtue of inclusion in the guideline.
Dated: January 13, 1995.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-2630 Filed 2-2-95; 8:45 am]
BILLING CODE 4160-01-F
