Development standards for a one-time gene therapy should be different from a drug taken regularly, CBER Director Peter Marks says.
Rare disease treatment sponsors and advocates may prefer all US Food and Drug Administration teams give the same development advice, but that may not be possible across all classes of products, regulators caution.
Inconsistent advice not only occurs within the FDA’s drug and biologic offices, but between the centers
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
