October 11, 2016. NCHR strongly supports the draft guidance documents because they place tight restrictions on pharmacy compounding under sections 503A and 503B of the FD&C Act to prevent compounding drug products that are essentially copies of commercially available drug products and for those that are copies of approved drugs.
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NCHR says YES to Ariel Grace’s Law
September 26, 2016. NCHR president Dr. Diana Zuckerman explains that the NCHR believes the bill is needed because “it provides an important incentive for manufacturers to do a better job of testing the safety of their implants and other devices. The incentive would be their desire to avoid law suits by patients harmed by defective high-risk medical devices.”
Read More »NCHR says YES to the Medical Device Guardians Act
September 26, 2016. NCHR supports this bill because there is clear scientific evidence that the vast majority of adverse events from medical products are not reported by physicians, and the percentage may be especially low for devices. “Since most devices are allowed to be without any scientific evidence of safety,” Zuckerman points out, “requiring adverse events to be reported by physicians is especially important.”
Read More »FDA Guidance Would Lower Safety Standards for High-Risk Medical Devices
September 14, 2016. NCHR strongly opposes this draft guidance. It does not enhance FDA’s goal of “protecting and promoting the public health.”
Read More »NCHR Supports FDA’s Guidance on Generic Drug Labeling Safety
September 9, 2016. NCHR supports this draft guidance, which is a step in the right direction for protecting the public health. However, the guidance should be broadened to include all situations, regardless of whether the RLD has been withdrawn. Moreover, to truly ensure that generic drug labels are updated in a timely manner, the FDA needs to finalize the proposed rule, “Supplemental Applications Proposing Labeling Changes For Approved Drugs and Biological Products.
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