Pink Sheet Podcast: Upcoming Opioids Policy Meeting, Improving US FDA's Rare Disease Legalese
Pink Sheet reporters discuss the proposed US opioid lawsuit settlement, Public Citizen's opioid citizen petition denial, and the upcoming US FDA public meeting on opioid standards, as well as a proposal to better outline agency flexibility with rare disease drugs.
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User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
President-Elect Biden also adds David Kessler and Andy Slavitt to his COVID-19 response team, retains Francis Collins at NIH director.