The FDA has a long and sordid history with the toxic compound diethylene glycol (DEG), having received much of its original regulatory authority after a major poisoning event in the 1930s attributable to it. But what’s past is prologue, and FDA is once again expressing concerns and the need for companies to test for the compound – and a similar one, ethylene glycol – following major international incidents and a string of recent FDA Warning Letters on the topic.
Regulatory Background
Sponsors typically formulate small molecule drug products with excipients to improve the delivery of an active pharmaceutical ingredient (API) to its intended site of action.
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