The Chief Scientist is denying a request for a hearing regarding the proposal by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or Agency) to refuse to approve a new drug application submitted by Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. The Chief Scientist denies approval.
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Denial of Hearing Request Regarding Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Order Refusing Approval
The Chief Scientist is denying a request for a hearing regarding the proposal by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or A...
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83 FR 54598
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“Denial of Hearing Request Regarding Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Order Refusing Approval,” thefederalregister.org (October 30, 2018), https://thefederalregister.org/documents/2018-23710/denial-of-hearing-request-regarding-proposal-to-refuse-to-approve-a-new-drug-application-for-oxycodone-hydrochloride-imm.