Gottlieb Nomination As US FDA Chief Could Signal Changes To Generic Approval Process
Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.
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Label updates for older generics are still planned, Commissioner Gottlieb says, but will depend more on sponsor collaboration as well as additional resources and authorities from Congress.
As then-Novartis CEO Joe Jimenez worked with former Trump lawyer Michael Cohen on drug pricing issues, the pharma industry was preparing for the debate it's eventually getting to have.