1. Pink Sheet

Gottlieb Nomination As US FDA Chief Could Signal Changes To Generic Approval Process

 
• By Michael Cipriano

Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.

President Donald Trump's choice of Scott Gottlieb to head the US FDA could signal efforts to bring reforms among a variety of fronts, perhaps none more notable than how the agency approves generic drugs.

Gottlieb, returning for what would be his third stint at the agency, has been a staunch proponent for flexible approval...

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