Medscape Medical News, March 29, 2016. Dr Diana Zuckerman explains that publication delays of drug watch lists illustrate how the FDA caters more to drug manufacturers than patients.
Read More »Author: NCHR Author
NCHR Testimony at FDA on Pimavanserin (Nuplazid) for Parkinson’s Patients with Psychosis
March 29, 2016. Because of concerns over the limited efficacy, the test used, and the high incidence of adverse events, NCHR urges FDA to not support the approval of pimavanserin [Nuplazid].
Read More »NCHR Supports Proposed FDA Regulation of Sunscreens
March 25, 2016. NCHR strongly supports the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are delineated in the draft guidance. The proposed testing requirements for new sunscreen chemicals will assure our country’s most vulnerable that the products will protect them from skin cancer and not cause unintended harm.
Read More »NCHR Comments on the Proposed Order Reclassification of Electroconvulsive Therapy Devices
March 28, 2016. Our review of the research indicates that ECT devices should remain as class III and should be subject to PMA review. The risks for patients associated with down classification of ECT devices for depression greatly outweigh any presumed benefit.
Read More »Can an Implant Stop Heroin Addiction?
The Daily Beast, March 27, 2016. Tracy Rupp told the advisory committee at the FDA that she was “disappointed to conclude” that the evidence wasn’t enough for her to endorse the opioid addition treatment. “While we all desperately want new treatments for opioid abuse, we have to be sure they are safe and effective,” she said.
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