NCHR Comments on FDA’s Draft Guidance on Patient-Focused Drug Development

September 11, 2018. We support FDA’s efforts to increase patient engagement and input into medical product development and testing. However, we recognize how challenging it is to ensure that the information will reflect the views and experiences of a representative sample of patients. That challenge must be met in order to develop treatments that have a more meaningful impact on patients’ lives with risks that patients consider acceptable.

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NCHR Comments to EPA on Principles to Applying Systematic Review in TSCA Risk Evaluations

August 16, 2018. Protecting the public health requires that EPA’s draft guidance for applying a systematic review process for risk evaluations is scientifically valid, reliable, and accepted by the scientific community. It should consider the totality of the scientific evidence without often irrelevant or industry-centric requirements that would reduce the impact of high quality sources or exclude them.

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