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.
Read More »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.
Read More »NCHR Testimony on RJRT’s Camel Snus Advertising
September 14, 2018. The NCHR testifies at the FDA advisory board committee for tobacco products regarding advertisements that target the youth.
Read More »NCHR Testimony on Pediatric Advisory Committee Meeting for Drugs Lexapro, Intuniv, and Desferasirox
September 20, 2018. NCHR Testimony on Pediatric Advisory Committee Meeting for drugs Lexapro, Intuniv and Desferasirox. This meeting was to go over the safety profiles of the aforementioned drugs, label profiles as well as recent clinical studies done.
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