| http://www.w3.org/ns/prov#value | - If the drug is a biologic, a Investigational New Drug Application or an application for a license under section 351 of the Public Health Service Act shall be submitted to the Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20014, in lieu of any submission to the Center for Drug Evaluation and Research. (4) The exemption referred to in
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