After receiving a complete response letter (CRL) for its immediate-release (IR) formulation of oxycodone hydrochloride, Pharmaceutical Manufacturing Research Services, Inc. (PMRS) requested a hearing on the US FDA's decision, arguing that the agency should not grant abuse-deterrent claims based on pre-marketing data while simultaneously seeking abuse-deterrent labeling for its own product, the agency say.
But FDA denied the company's request for such a hearing, leaving the sponsor a clear message: You can't have it...