Trump's HHS con­tin­ues to as­sert au­thor­i­ty over FDA in twi­light of his pres­i­den­cy, im­ple­ment­ing new drug time­line rules

With less than 10 days to go be­fore a new ad­min­is­tra­tion comes in, Alex Azar’s HHS is im­ple­ment­ing key changes at the FDA that are re­port­ed­ly rais­ing alarms among cur­rent and for­mer staffers about the agency’s in­de­pen­dence.

Azar en­act­ed two new poli­cies aimed at dereg­u­lat­ing FDA re­view poli­cies for new drug ap­provals and med­ical de­vices, HHS an­nounced late Mon­day. The first re­quires the agency to pub­lish its time­line for every NDA and AN­DA re­view on its web­site, while the sec­ond ex­empts a range of de­vices from pre­mar­ket re­view en­tire­ly.

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