Politico, March 2, 2021: The FDA is under pressure from the pharmaceutical industry to address the growing backlog of drug inspections — nearly a year after Covid-19 prompted the agency to halt most plant visits. From March through September, FDA inspected just three plants outside the U.S. and 52 within the U.S., well below the 600 and 400, respectively in each of the prior two years. NCHR president reports device inspections have also dropped dramatically
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine
ScienceNews: February 27, 2021. On February 27, the FDA authorized Johnson & Johnson’s COVID-19 vaccine for use in the U.S. The other two authorized vaccines are made by Pfizer and Moderna. None are FDA approved. All show effectiveness, but there are too few serious COVID-19 cases in any of the studies to conclude how well it prevents hospitalizations or deaths.
Read More »J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel
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.
Read More »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 »