Politico, January 14, 2020. The FDA is reviewing a handful of pain medications, including some new opioids, as the country continues to struggle with misuse and addiction to narcotics.
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Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound
MedTech Dive, January 10, 2020. FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020.
Read More »Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants
December 23, 2019. We are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person is considering surgery.
Read More »Reports Of Patients’ Deaths Linked To Heart Devices Lurk Below Radar
Kaiser Health News, December 24, 2019. It is so problematic that the FDA continues to file thousands of reports of patients’ deaths related to medical devices out of the public eye.
Read More »Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels
MedTech Dive, December 23, 2019. As the FDA approves medical devices, it is essential that the public is made aware of inadequate post-approval studies and spotty adverse event reporting.
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