Medscape Medical News: February 26, 2021. An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine, but several researchers expressed concerns to the panel about the lower standards of EUAs, including NCHR’s president Dr. Diana Zuckerman.
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Who Will Be the Next F.D.A. Chief?
The New York Times: February 20, 2021. One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review. This has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.
Read More »FDA blasts Merck’s Keytruda data for new breast cancer indication
Stat News, February 5, 2021. The cancer drug Keytruda is a medical and financial juggernaut, but it may not win FDA approval for early-stage triple negative breast cancer. FDA medical reviewers agreed there is a need for new treatments, but Keytruda did not impress them with its small benefit of “questionable clinical meaningfulness” and serious safety issues. NCHR’s Dr. Zuckerman said “This is one of the most negative reviews I’ve ever seen.”
Read More »Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation
MedTech Insight: January 19, 2021. HHS plans to waive regulatory review of more than 80 different types of medical devices granted, but advocates have concerns.
Read More »New Trump Administration Policies for FDA Under Fire
Medscape, January 15, 2021. New policies will weaken regulations on medical products if the Trump administration passes them before leaving.
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