GUIDANCE DOCUMENT
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry July 2019
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-2153
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance provides recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy . Drug product development in hormonal contraception has evolved over the years, especially with the development of lower-dose hormonal drug products and longer-acting reversible contraceptives. Changes in patient demographics, pregnancy testing, determinations of conception date, and dosing directions have also occurred. This guidance reflects these developments and is generally consistent with advice we have been providing to individual sponsors developing hormonal drug products.
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2019-D-2153.