FDA Meeting – Off-Label Use of Medical Products

Testimony Delivered at the FDA Public Meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products November 10, 2016 [FDA Docket No. FDA-2016-N-1149] 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 … 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Comments on the Draft Guidance: Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices [Docket No. FDA-2016-D-2153]   The National Women’s Health Network is a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