The FDA has recently given emergency authorization to extend the shelf-life of at-home test kits, adding an additional 3-6 months to the expiration date printed on the box.
Read More »Author: Caroline Bradford
These machines to help people breathe were recalled a year ago. Many still use them
Los Angeles Times, June 23, 2022: CPAP, BiPAP, and other ventilators made by Philips that help people stay alive were recalled more than a year ago. But patients haven’t been informed and others can’t live without them unless there is a replacement device that they can afford. FDA is now pressuring Philips to replace them.
Read More »Patient, Consumer, and Public Health Coalition Letter to Senate HELP on the Updated Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA)
June 13, 2022: While pleased with many of the changes in the updated bill introduced on May 26, we continue to have serious concerns regarding a number of provisions, including: lack of sufficient post-market surveillance of medical devices; several weaknesses regarding accelerated approval reform; lack of bill language to improve the diversity of patients in clinical trials used as the basis of FDA approval decisions; and the lack of post-market surveillance activities in the VALID Act.
Read More »Patient, Consumer, and Public Health Coalition Letter to Congresswoman Dingell Thanking Her for Requesting a GAO Report on Post-market Surveillance of Medical Devices
June 7, 2022: We write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices.
Read More »NCHR’s Testimony to FDA on the Novavax COVID-19 Vaccine
June 7, 2022: While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine?
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