June 8, 2022. FDA announced that the risks of BELVIQ outweigh any potential benefits and withdrew the drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”. Delaying the inclusion of unsafe drug products poses an entirely avoidable risk for patients. An inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.
Read More »Tag: FDA Advisory Committee
NCHR’s Testimony to FDA on End of Induction Response in High-Risk Neuroblastoma
May 12, 2022. Clinical benefits should remain the key endpoints for approval decisions of these treatments. Surrogate endpoints that predict clinical benefits are not yet established and until they are, we are concerned about their use as secondary endpoints unless the primary endpoint is also met.
Read More »Testimony of Dr. Diana Zuckerman About IV Tramadol Before FDA Advisory Committee
February 15, 2022: NCHR testifies against the opioid, tramadol, administered by IV to the FDA Advisory Committee.
Read More »NCHR’s Testimony at FDA Advisory Meeting on Teplizumab to Delay Type 1 Diabetes
May 27, 2021. FDA scientists note substantial problems with the study sample. These study shortcomings are even more worrisome since the sample was very small.
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.
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