FDA Meeting – Risk Benefit Assessment

Testimony Delivered at the FDA Public Meeting on Benefit-Risk Assessments in Drug Regulatory Decision-Making September 18, 2017 [FDA Docket No. FDA-2017-N-4076]   My name is Caila Brander and I am the Policy Coordinator at The National Women’s Health Network, a nonprofit advocacy organization that works to improve the health of all women. We are supported … Continued

FDA Comments – Real World Evidence & Essure

Comments on the Draft Guidance: Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices [Docket No. FDA-2016-D-2153]   The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. We are supported by our members and do not accept financial support from insurance companies, drug … Continued

FDA Scientific Workshop – Labeling of Low-dose Vaginal Estrogen Products

Statement of Cindy Pearson, Executive Director, National Women’s Health Network Food and Drug Administration Scientific Workshop on Labeling Lower-Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy My name is Cindy Pearson, and I am the Executive Director of The National Women’s Health Network. The National Women’s Health Network is a nonprofit advocacy organization that … Continued

FDA Meeting – Essure

Testimony Delivered at the Meeting of the FDA Meeting of the Obstetrics and Gynecology Devices Panel September 24, 2015 My name is Cindy Pearson, and I am the Executive Director of The National Women’s Health Network. The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. … Continued