April 25, 2016. U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works.
Read More »On Health Policy
NCHR Testimony at FDA on Hearing Aid Good Manufacturing Practices
April 21, 2016. We support the need to improve access to high quality hearing aids and other medical devices for the aging population. However, we are very concerned that there is a heavy focus on increasing the adoption of hearing aids that is not balanced by strong explicit attention to safety or to devices that work well for the individuals buying them. We recommend stronger evidence explaining and supporting the safety and effectiveness of devices that impact hearing.
Read More »Letter to House Members Opposing Language Added to the Appropriations Bill that Lowers the FDA’s Safety and Efficacy Standards for Drugs and Devices
April 15, 2016. The National Center for Health Research strongly opposes language added at the last minute to the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017. The language lowers the FDA’s safety and efficacy standards for approving drugs and medical devices and will put the public health at risk. These are the same provisions that members of the Patient, Consumer, and Public Health Coalition have previously opposed. We urge you to oppose including in the appropriations bill language that lowers FDA’s standards for drugs and devices.
Read More »Establishing Paid Sick Leave for Federal Contractors
April 12, 2016. The federal government provides paid sick leave to its employees, but not those who work indirectly for the federal government as contractors. This rule would extend sick leave for an estimated 828,000 employees.
Read More »NCHR Supports Proposed FDA Regulation of Sunscreens
March 25, 2016. NCHR strongly supports the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are delineated in the draft guidance. The proposed testing requirements for new sunscreen chemicals will assure our country’s most vulnerable that the products will protect them from skin cancer and not cause unintended harm.
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