May 17, 2012. To ensure public health and patient safety, sorbent hemoperfusion devices for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances should remain class III devices and go through the more stringent PMA process, which requires clinical trials and inspections.
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NCHR Testimony on Lorcaserin
May 10, 2012. Sonia Nagda, a Senior Fellow at NCHR, testifies at an FDA advisory committee meeting on the weight loss drug Lorcaserin.
Read More »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.
Read More »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.
Read More »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.
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