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Opioid 'Data Warehouse' Is Part Of US FDA's New Controlled Substances Program

 
• By Derrick Gingery

CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.

An ampoule Opioid next to it is a note written in English Opioid epidemic. All around, many tablets and syringes are scattered.
The FDA's new opioid data warehouse, intended to collect data related to the crisis and inform regulatory change, also will come under the CSP purview. • Source: Shutterstock

Controlled substance activities now are under one umbrella at the US Food and Drug Administration’s Center for Drug Evaluation and Research, a promotion of sorts as the agency’s response to the opioid crisis grows.

A new Controlled Substances Program (CSP) has been established at CDER, which will house the Controlled Substances Staff and the Controlled Substances Initiatives team, Deputy CDER Director for Regulatory Programs...

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