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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Industry groups, along with many rare disease and patient advocacy groups, appear behind the acting commissioner getting the permanent position.
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.