June 7, 2022: While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine?
Read More »Tag: Advisory Committee
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 »NCHR’s Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting
February 26, 2020. We oppose approval of this indication of Cyramza without evidence that it improves overall survival enough to outweigh the risk for adverse events and reduced quality of life.
Read More »NCHR Testimony on Aximris as an Abuse-Deterrent Opioid for Long-Term Treatment
January 15, 2020. FDA should require sufficient evidence that this drug’s abuse-deterrent properties will result in meaningful reductions in abuse, misuse, and related adverse clinical outcomes.
Read More »NCHR Testimony on Tramadol and Celecoxib for Acute Pain Relief
January 15, 2020. There is absolutely no evidence that this combination drug with an opioid is as effective or more effective than a standard dose of just the NSAID.
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