Legal Reader, November 9, 2021: Will FDA’s requirements to warn patients about the cancer risks and other serious risks of breast implants be enough to adequately warn women considering implants? Experts disagree.
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More efficacy data needed for Levo’s PWS treatment
BioWorld, November 4, 2021: Prader-Willi syndrome (PWS) is a terrible disease. But Levo Therapeutics research evidence for their nasal spray to prevent uncontrollable eating is among the worst we’ve seen at National Center for Health Research.
Read More »Patients Must Be Warned of Breast Implant Risks, F.D.A. Says
The New York Times, October 27, 2021: The FDA has placed black box warnings on breast implant packaging and told manufacturers to sell the implants only to health providers who review the potential risks with patients before surgery, and tell them the risks are even higher for breast cancer patients. The National Center for Health Research asks who will enforce that?
Read More »Testimony of Dr. Diana Zuckerman, NCHR, at the FDA MDUFA Meeting
September 30, 2021: Dr. Diana Zuckerman testifies to the FDA regarding the lack of diversity and inclusion in medical device trials pointing out that most medical companies do not adequately study safety and effectiveness in women, older patients, and people of color.
Read More »How Fauci and the NIH Got Ahead of the FDA and CDC in Backing Boosters
KHN, September 16, 2021: How did Fauci and the NIH and the White House get ahead of the FDA and CDC in backing boosters? NCHR’s president explains the conflicting perspectives. And when the data are not conclusive, the question is what is the best strategy for you? And to defeat the pandemic? They may not be the same.
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