Ruining The Mood, US FDA Says Glycerin, Oleate Cream Not Approved As OTC Contraceptive
Smart Women’s Choice promotes its namesake brand topicals with claims including “One hundred percent hormone-free, completely safe, natural birth control that cannot fail when used as directed and causes no harmful side effects,” FDA warning says.
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FDA and FTC jointly warn five marketers of supplements with claims to treat fertility and other reproductive disorders. The unapproved and misbranded drugs could harm consumers and deter them from seeking effective treatments.
Health And Wellness On Capitol Hill: Monograph Reform, Wyden On CBD Rule, OTC Daily Contraceptive Access
Energy and Commerce members try again on monograph; Democrats want to ensure OTC oral contraceptive access; Wyden asks for faster CBD rulemaking at FDA; and House passes FDA's FY 2020 funding.
HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.