(Reuters) -Richard Pazdur, who recently took over as the head of U.S. FDA’s drug evaluation department, has raised concerns about the legality and pace of new initiatives to expedite decisions, the Washington Post reported on Friday, citing three people familiar with the matter.
The agency’s veteran oncology chief Pazdur took over the new role earlier this month, replacing George Tidmarsh, who resigned amid serious concerns about his personal conduct.
Pazdur has questioned several plans developed by FDA Commissioner Marty Makary, warning that they could pose a risk to public health, the report added.
The two have disagreed over the commissioner’s plan to reduce the number of research studies needed to justify more drug-related decisions, such as changes to drug labels, the report said, citing two people.
The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment.
(Reporting by Sriparna Roy and Padmanabhan Ananthan in Bengaluru; Editing by Leroy Leo)
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