NCHR Testimony on Peanut Allergen Powder for Children with Peanut Allergy

September 13, 2019. This is the first treatment for peanut allergies and if this drug is approved despite the unanswered questions, it will set a precedent for future drugs to treat food allergies. It is especially important that new classes of products provide strong evidence of safety and efficacy before approval, because it will be difficult if not impossible to obtain it afterwards.

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NCHR Comment on FDA’s Draft Guidance to Industry on Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy

September 10, 2019. We strongly urge the FDA to convey to industry the need for a comparison group instead of historical controls, the need to conduct subgroup analyses of the safety and efficacy of hormonal contraceptives for each of several major patient populations, and the importance of premarket studies that quantify the likelihood of adverse events for different subpopulations.

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