The U.S. Food and Drug Administration today issued a new draft guidance, “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy” which, if finalized, would include recommendations regarding key design features for clinical trials planned to establish effectiveness and safety for hormonal contraceptives intended to prevent pregnancy. This draft guidance does not address development of contraceptive devices for this indication.
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. If finalized, this guidance would reflect these progressions and align with advice the FDA has been providing to individual companies developing hormonal contraceptives.
Print Page
Email to a Friend