September 11, 2012. Sonia Nagda, a Senior Fellow at NRC, testifies at a Pediatrics FDA Advisory Committee meeting on the use of drospirenone-containing oral contraceptive, Beyaz, in pediatric populations.
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Testimony at FDA Advisory Committee Hearing on Metal-on-Metal Hip Implants
June 27, 2012. Metal-on-metal hip implants were approved by the FDA without requiring clinical studies before approval or following patients after their surgery for potential side effects. Now, 500,000 patients have metal-on-metal implants that have been widely reported to wear down and create metal debris inside patients’ bodies. Dr. Zuckerman testifies to the FDA about the lack of long-term clinical trials at their Advisory Committee hearing.
Read More »Testimony to FDA Advisory Committee on Atrial Septal Defect Occluders
May 4, 2012. Sonia Nagda, a Senior Fellow at NRC, testifies at an FDA advisory committee meeting on the post-market studies of atrial septal defect occluders.
Read More »Comments on Sorbent Hemoperfusion Devices for the Treatment of Poisoning, Drug Overdose, Hepatic Coma, and Metabolic Disturbances
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.
Read More »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.
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