On Medical Treatments & Products Archives

Letter to Dr. Woodcock, FDA Director for the Center for Drug Evaluation and Research, on the Approval of Qnexa, a Weight-Loss Drug

April 16, 2012. In this letter, NCHR and other women’s organizations urge the FDA to not approve Qnexa, a weight loss drug, because of serious unresolved safety concerns about its potential to cause cardiovascular harm and birth defects.

Comment on a FDA Guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies

March 19, 2012. The National Research Center for Women and Families has been a long-time advocate of medical device clinical studies including data on safety and effectiveness for women. In this comment letter to the FDA, we describe the importance of analyzing data for women separately and how this information should be used to help women and providers make the best informed decisions.

Letter to Dr. Hamburg, FDA Commissioner on the Review of Drospirenone (DRSP)-Based Oral Contraceptives

March 9, 2012. When oral contraceptives first became available, comparing risks and benefits of oral contraceptives to pregnancy was the right question.

NCHR Testimony on Classification for Cranial Electrotherapy Stimulators

February 10, 2012. This testimony supported the FDA’s position that the available scientific evidence does not support reclassifying Cranial Electrotherapy Stimulators to a medical device category with lower risk.

FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data About Quality of Life, Connective Tissue Symptoms, Rupture Rates Per Patient, and Other Complications

January 5, 2012. At the FDA Advisory Panel meetings in 2003 and 2005, FDA provided and presented data from the Breast Implant Core studies regarding connective tissue disorder (CTD) signs and symptoms (S/S) and Quality of Life measures.