On Health Policy Archives

NCHR Testimony to the FDA Patient Engagement Advisory Committee on Medical Devices

November 15, 2019. NCHR testified to the FDA regarding social media surrounding medical devices, and how it affects patient engagement.

NCHR Comments on FDA’s Draft Guidance on Patient-Focused Drug Development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

NCHR’s Comments to EPA on Problem Formulations for Risk Evaluations under TSCA for Ten Chemicals

August 16, 2018. We oppose the EPA’s proposed “problem formulations” because they would not adequately evaluate exposure, harm or risk. They would exclude many of the uses, exposures, and hazards that would have been included in the risk evaluations that were planned as part of the scoping documents.

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 Protecting the public health requires that EPA’s draft guidance for applying a systematic review process for risk evaluations is scientifically valid, reliable, and accepted by the scientific community.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.

Comments on FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs

August 13, 2018. Everyone agrees that there is a need to develop new antimicrobials to treat serious or life-threatening infections. The only way to make sure that new drugs are safe and effective is by requiring well-designed and valid clinical trials.