Category: Uncategorized

ARCS, ARID, ARIM, FDA, Uncategorized

Last Minute Help on FDA Marketing Status Report

The US Food and Drug Administration (FDA) wants your valentines, or at least a letter saying that you love them so much, because they accurately listed your products in the “Approved Drug Products with therapeutic Equivalence Evaluations,” better known as the Orange Book. As part of the FDA Reauthorization Act of 2017 (FDARA), there is …

Conferences, Uncategorized

DIA Canada October 16-18

Sorry for the short notice, but please come hear me present IDMP: International Data, Multiple Processes at the DIA Canada annual meeting in Ottowa October 16-18. I will be speaking in session 4C at 3:30PM on October 17, in the session Identification of Medicinal Products (IDMP)- Updates and Implementation Approaches, chaired by Maggie Graham of Health …