February 6, 2014. As members of the Patient, Consumer, and Public Health Coalition, we conditionally support the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding.
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NCHR Testimony on NIOSH Draft Intelligence on Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace
December 16, 2013. When notorious and decades-known carcinogens such as asbestos and radon are still present at unsafe or unknown levels in American workplaces, how can the public have confidence that our regulations can handle new and complex occupational hazards arising every day?
Read More »NCHR Testimony on Classification of Stair-climbing and Mechanical Wheelchairs
December 12, 2013. Stair-climbing wheelchairs are have been considered high risk – Class III – and have been required to submit studies of safety and effectiveness under the PMA review process. The proposed order would reclassify stair-climbing wheelchairs into Class II indicating moderate risk, and reviewing it through the 510(k) process.
Read More »NCHR Testimony on Classification of Spinal Sphere Devices
December 12, 2013. For classification of spinal sphere devices, we support FDA in considering a Class III designation for these devices.
Read More »Letter in Support of the Whistleblower Protection Act
November 19, 2013. As members of the public health community, we write to urge you to support the Warner-Collins-Kaine-Grassley amendment to the National Defense Authorization Act for FY 2014 (NDAA, S. 1197).
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