April 30, 2014. We strongly support the FDA decision to require proof of safety and effectiveness of surgical mesh for pelvic organ prolapse (POP) in clinical trials.
Read More »On Medical Treatments & Products
Statement of Dr. Diana Zuckerman Regarding FDA’s Announcement About Power Morcellation Devices for Uterine Fibroids and Other Uterine Surgery
April 17, 2014. We thank FDA for discouraging surgeons from using an FDA-approved device for women with uterine fibroids.
Read More »Coalition Letter to FDA Center for Drug Evaluation and Research About Flibanserin or “Pink Viagra”
April 8, 2014. As members of the Patient, Consumer, and Public Health Coalition, we are writing to support the agency’s evidence-based evaluation and decision regarding flibanserin.
Read More »NCHR Comment to FDA Advisory Committee on Anti-Infective Drug Sivextro
March 31, 2014. We have concerns about Sivextro for the treatment of adult patients with acute bacterial skin and skin structure infections. The main goal in antibiotic drug development is finding new drugs to target strains that are resistant to currently available drugs.
Read More »NCHR Comments to FDA Advisory Committee on Anti-Infective Drug Dalvance
March 31, 2014. A careful analysis of the data calls into question the efficacy of Dalvance (Dalbavandin)… statistics indicate Dalbavandin patients are approximately twice as likely to have worse clinical outcomes compared to patients taking the comparison drug, vancomycin.
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