FDA commissioner Scott Gottlieb just broke a public promise on publishing CRLs — and yes, it matters
In his testimony to the US Senate during his confirmation hearings to lead the FDA, Scott Gottlieb clearly enunciated his position on publishing the complete response letters the FDA sends to biopharmas when regulators reject their new drug applications.
Vowing to achieve greater transparency, Gottlieb promised to open up more. He wrote: “This includes the complete response letters, after proper redaction of commercial confidential information.”
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