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

NWHN Statement to the FDA: Benefit-Risk Assessment in Drug Regulatory Decision-Making

Statement of Caila Brander, Policy Coordinator Presented to the U.S. Food and Drug Administration Benefit-Risk Assessment in Drug Regulatory Decision-Making Request for Public Comments 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 … 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Comments on the Draft Guidance: Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices [Docket No. FDA-2016-D-2153]   The National Women’s Health Network is a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