alt Hacker NewsIt's an FDA guidance doc so you can expect to see this affecting new filings or supplemental filings for upcoming FDA submissions and clinical trial designs. This is good news, statistical plans are always a point of contention during trial design and the submission process. This guidance lays a line in the sand and will remove some of the reviewer-to-reviewer variance present in the current FDA staff.
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> This guidance lays a line in the sand and will remove some of the reviewer-to-reviewer variance present in the current FDA staff.
That would be nice, but my experience is there can be quite significant variability between reviewers in different teams/groups, even on topics you'd think were well-established for many years, and for which there is existing FDA guidance.
> 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.