Varuna Srinivasan, MBBS, MPH, National Center for Health Research, May 24 2019 In 2015, the FDA approved the drug Addyi for women with low sexual desire disorder that is not due to a medical or mental health problem, medicines, drug use or relationship problems.[1] Addyi is a pill that must be taken daily, not just when a woman wants to “get in […]
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NCHR Testimony at FDA at the Onolcogy Drugs Advisory Committee Meeting on Quizartinib
May 14, 2019. We need new treatments for this deadly disease, but we need to know if a new drug is BETTER than existing treatments. The fact that Quizartinib is quite similar in risks and benefits to chemo, which is not very effective and provides a poor quality of life, is not a good reason to approve this drug.
Read More »NCHR Testimony at FDA at the Onolcogy Drugs Advisory Committee Meeting on Pexidartinib
NCHR testified against the drug Pexidartinib for Giant Cell Tenosynovitis patients for whom surgery is not an option for reasons being that the drug was not tested adequately and has serious side effects associated with its use.
Read More »NCHR Comments on Modernizing FDA’s 510(k) Program
May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.
Read More »NCHR Testimony on Mannitol Inhalation Powder for Cystic Fibrosis
May 9, 2018. It is uncertain if the benefits outweigh the risks based on the data discussed today. However, there should be sufficient evidence of both safety and efficacy before approval.
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