Kevin Stawicki, Law360, November 12, 2019. The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program. The […]
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How the FDA and EPA’s Failure to Communicate Could Put Patients in Danger
Politico, November 7, 2019. While EPA wants to shut down facilities that sterilize medical devices using a carcinogenic chemical, the EPA and FDA should have harmonized their standards years ago to protect patients and consumers.
Read More »As Essure Implant Return Deadline Nears, FDA Study Enrollment Inches Up
MedTech Dive, November 5, 2019. The original clinical data supporting FDA’s approval of Essure was insufficient, as seen in Bayer’s small sample size in the Essure postmarket study.
Read More »FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns
Kaiser Health News and Daily Beast, November 3, 2019. More caution is warranted as the FDA keeps brand-name drugs on the fast path to the market, despite concerns about manufacturing and pre-market inspections.
Read More »When Recalls Fail: Many harmful products remain in homes and stores. Why that happens, what needs to change, and how to protect yourself.
Consumer Reports, October 31, 2019. Whether it be contaminated food, deadly infant sleepers, breast implants, or other unsafe products, recalls are not protecting us as well as they should be.
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