NCHR Testimony on Antidepressant Brexanolone for Postpartum Depression

Dr. Varuna Srinivasan, MBBS, MPH, National Center for Health Research, November 2nd 2018 Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes […]

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NCHR Testimony on the Opioid Buprenorphine/Samidorphan for Depression

November 1, 2018. The clinical trial data do not provide adequate evidence that buprenorphine/samidorphan reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.

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NCHR Testimony on the Opioid Oliceridine

October 11, 2018. There are many unanswered questions about what dosages work and are safe for which patients under which conditions. We all know that is an epidemic of opioid use, so these questions must be answered before a decision is made about whether or not to approve oliceridine.

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NCHR Testimony on WEB Aneurysm Embolization System

September 27, 2018. There are important aspects of the clinical trial that make it difficult to determine if the WEB device is effective and safe for the indicated population. If the FDA does not demand better research, patients and their physicians may never know the answers to those questions.

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