Curious comment by president could place US FDA Commissioner in tough spot balancing his boss' priorities with his and staff's concerns about pending right-to-try legislation.
President Trump has put FDA Commissioner Scott Gottlieb at the front of his push to pass right-to-try legislation, whether Gottlieb wanted to be there or not.
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CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.
PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.
The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.
