Large Compounders’ Reporting Requirements Would Move Closer To Manufacturers’ In Senate Bill
This article was originally published in The Pink Sheet Daily
Compounding manufacturers would have to report adverse events and quality problems much like traditional drug and biologic makers as a Senate committee moves toward mark up of legislation.
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After House Republicans indicate legislation expanding agency’s oversight of compounding is unlikely, FDA could consider other regulatory options, like changing internal policies or hoping a court clarifies its regulatory authority.
Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.