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Browse our FDA ADVOCACY work:
The public pays for more than half of the FDA's budget each year, which entitles us to have a say in the agency’s operations. Late last year, we gave your predecessor, Scott Gottlieb, a report card on his first year...
The NWHN’s Statement on the FDA Ordering Manufacturers of Surgical Mesh to Stop Selling Devices for Uterine ProlapseBy: Cindy Pearson ,FDA Advocacy, Gynecological Health, Pelvic Organ Prolapse, Surgical Mesh, Transvaginal Mesh Press Releases
FOR IMMEDIATE RELEASE Contact: Evita Almassi, firstname.lastname@example.org or (202) 682-6240
Earlier in March, the FDA sent warning letters to two breast implant manufacturers, Mentor and Sientra, citing their failure to conduct safety studies after approval. In Australia and France, authorities have been pulling textured implants off the market due to...
In 2016, the FDA reclassified transvaginal mesh used to repair pelvic organ prolapse (POP) as a Class III device—the highest risk category—in response to over 20,000 adverse event reports during a three-year period alone.
We have made progress as a country, but there is still work to be done. Clinical trials need to broaden their subject base and do a better job of representing all affected parties for the sake of equality and the...
Testimony Delivered at the Meeting of the FDA Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee