Politico Pulse, April 28, 2021: Will FDA maintain approval for cancer drugs that are proven to not work? We were hoping for a reckoning, but that doesn’t seem likely as the doctors on the FDA Advisory panel tell FDA that they are hopeful that the drugs will eventually be proven to work.
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NCHR Statement at FDA Advisory Committee Meeting on Tecentriq for Triple Negative Breast Cancer
April 27, 2021: A new randomized controlled trial that includes more Black women is needed to evaluate Tecentriq for Triple Negative Breast Cancer in order to keep FDA approval. The FDA doesn’t do patients any favors by continuing to approve a treatment that isn’t shown to help and may actually harm them.
Read More »Conflicts Galore: Upcoming Accelerated Approval Cancer Panel Includes Many Industry Relationships
Pink Sheet, April 21, 2021. Six members of the FDA Oncologic Drugs Advisory Committee had conflicts of interest requiring waivers to participate in the agency’s April 2021 meeting to review whether 3 cancer drugs should have their indications for late-stage breast cancer, bladder cancer, and gastric cancer removed from the market due to lack of evidence that they are effective.
Read More »The FDA Cut Off COVID Vaccine Testing. That Was a Really Bad Idea.
Washington Monthly, March 26, 2021: Not since the polio vaccine became available in April 1955 have Americans been so excited about getting a shot. But behind the scenes, there’s a lot we don’t know because of a decision made back in December by the FDA. The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines, making it impossible to learn how long the vaccines work and for whom.
Read More »Statement of Diana Zuckerman, Ph.D On Behalf of the National Center for Health Research Before the FDA Advisory Panel Convening to Discuss Dermal Fillers
March 23, 2021: A black box warning is needed, should be prominently displayed, and should include warnings about off-label uses as well as approved indications and well-trained providers.
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