NCHR Testimony at the FDA about New Spine Device, Barricaid Anular Closure

Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Danielle Shapiro, I am a physician and senior fellow. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. Those are the perspectives I bring with me today. […]

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NCHR Testimony at the FDA about Ciprofloxacin Dry Powder Inhaler (DPI) for Non-Cystic Fibrosis Bronchiectasis

November 16, 2017. We do not know enough to approve this drug for people who really need it, and we respectfully urge you to consider the inadequacy of the current data. We recommend further study of this drug with clinically meaningful primary endpoints, such as severity of exacerbation, overall lung function, and patient-reported outcomes to directly assess patients’ symptoms such as cough, wheezing, and sputum production. We also recommend comparing the drug to a non-powder to ensure that the method of use does not worsen symptoms and including more patients 75 and older.

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NCHR Testimony at the FDA about Depot Buprenorphine, RBP-6000

October 31, 2017. In conclusion, to reduce deaths and addiction due to opioids, we must demand more from everyone. Prescribers must be better informed, REMS and ETASU (Elements to Assure Safe Use) must be sufficiently stringent, and scientific methods used to assess treatments must be sound. Given serious risks and concerns outweigh this drug’s minimal benefits, we cannot recommend approval of this drug based on current data.

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NCHR Testimony at the FDA about Depot Buprenorphine, CAM2038

November 1, 2017. In conclusion, we all want more options to reduce opioid addiction, but if the FDA approves treatments that are less safe and less effective than those already available, we are worried that this will not help. Scientific methods used to assess treatments must be sound. Specific doses need to be evaluated for safety and effectiveness based on reasonable sample sizes for at least 24 weeks. Given potentially serious risks that outweigh this drug’s minimal benefits, we cannot recommend approval of this drug based on current data.

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