The Verge, March 17, 2021: The FDA has allowed a second digital birth control app to be sold in the U.S. Neither Natural Cycles nor Clue were tested in clinical trials. NCHR asks how safe and effective are they, and are women being misled?
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As Essure Implant Return Deadline Nears, FDA Study Enrollment Inches Up
MedTech Dive, November 5, 2019. The original clinical data supporting FDA’s approval of Essure was insufficient, as seen in Bayer’s small sample size in the Essure postmarket study.
Read More »NCHR Testimony on New Contraceptive Patch by Agile Therapeutics
October, 30 2019. The FDA held an Advisory Committee meeting to discuss the safety and effectiveness of a new contraceptive patch by Agile Therapeutics. The Committee voted that the benefits of the patch to prevent pregnancy outweigh the risks.
Read More »NCHR Comment on FDA’s Draft Guidance to Industry on Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy
September 10, 2019. We strongly urge the FDA to convey to industry the need for a comparison group instead of historical controls, the need to conduct subgroup analyses of the safety and efficacy of hormonal contraceptives for each of several major patient populations, and the importance of premarket studies that quantify the likelihood of adverse events for different subpopulations.
Read More »Trying to Get Pregnant or Trying to Avoid it? Now, There Are Apps for Both!
Digital birth control apps are becoming more common. The FDA has now cleared two apps: Natural Cycles and Clue for preventing pregnancy. Read more about why these apps are unreliable for women looking to avoid pregnancy.
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