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Zdrowie i gospodarka · 30/10/2018

FDA Chief Scientist Denies Hearing Request on Oxycodone Hydrochloride Drug Application Proposal

The FDA's Chief Scientist has denied a request for a hearing regarding the FDA's proposal to refuse approval of a new oxycodone hydrochloride drug application submitted by PMRS, citing the current formulation of the drug as not meeting safety standards.

Source: Federal Register — Food and Drug AdministrationOpen original release →