federal_register: 95-2631
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
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| 95-2631 | Vaginal Contraceptive Drug Products for Over-the-Counter Human Use | Proposed Rule | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would require manufacturers of over-the- counter (OTC) vaginal contraceptive drug products to obtain approved applications for marketing of their products. The agency is taking this action because the effectiveness of these products is dependent upon the final formulation. Therefore, each product must be tested in appropriate clinical trials under actual conditions of use. This action will ensure the maximum effectiveness of OTC vaginal contraceptive drug products for consumers. This proposed rulemaking does not affect the current marketing status of OTC vaginal contraceptives. Thus, persons who are using or wish to use these drug products may do so. However, on the effective date of a final regulation, an OTC vaginal contraceptive drug product that is not the subject of an approved application would be regarded as a new drug and subject to regulatory action. Manufacturers will have adequate time to conduct studies and submit applications before the effective date of the final rule. Under existing procedures, there is a minimum of 26 months from today before a final rule could become effective. Despite this timeframe, manufacturers are urged to contact the agency regarding submission of their application as soon as possible. OTC contraceptives that are marketed for use with or as part of a device, e.g., diaphragm, condom, or contraceptive cervical cap will not be addressed in this document but will be addressed in a separate publication. FDA is issuing this notice of proposed rulemaking after considering the report and recommendations of the Advisory Review Panel on OTC Contraceptives and Other Vaginal Drug Products, public comments on an advance notice of proposed rulemaking that was based on those recommendations, and evolving new information about these products. This proposal is part of the ongoing review of OTC drug products conducted by FDA. While this document does not address the use of vaginal contraceptive drug products for prophylaxis against human immunodeficiency virus (HIV) and other sexually transmitted diseases (STD's), FDA is aware of literature reports and other data relative to such use. FDA strongly encourages manufacturers to evaluate these products for use in the prevention of infectious diseases. | 1995-02-03 | 1995 | 2 | https://www.federalregister.gov/documents/1995/02/03/95-2631/vaginal-contraceptive-drug-products-for-over-the-counter-human-use | https://www.govinfo.gov/content/pkg/FR-1995-02-03/pdf/95-2631.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would require manufacturers of over-the- counter (OTC) vaginal contraceptive drug products to obtain approved applications for marketing of their products. The... |