| > This guidance lays a line in the sand and will remove some of the reviewer-to-reviewer variance present in the current FDA staff. https://www.statnews.com/2026/01/13/richard-pazdur-jpm-fda-c... Recent comments during JPM don't have me hopeful for smooth sailing at the FDA any time soon. > He said he was also deeply troubled by agency staff “being trampled on.” He referred to one individual who was “writing inflammatory emails using the F bomb,” telling center directors and deputy center directors that “they will go after them, that they were going to lose their jobs if they did not play ball.” > He would also not name this person. STAT has reported that employees have been fearful under Vinay Prasad, director of the Center for Biologics Evaluation and Research. > “It’s terrible to see 25 years of work dismantled,” said Pazdur, who founded the FDA’s oncology center. He later added, “I did not leave because I wanted to leave.” > “I think I have been consistently critical of parts of the FDA regardless of administration, but what’s emerged over the past few months is just reflective of complete and total disarray and a complete lack of functional leadership,” said Brian Skorney, an analyst at the investment bank Baird. |