Search results with tag "New drug 3"

DRAFT GUIDANCE ON APPROVAL OF CLINICAL …

GUIDELINES ON APPROVAL OF CLINICAL TRIAL & NEW DRUGS Effective Date: Page 4 of 71 DRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIAL & NEW DRUG 3 BACKGROUND Demonstration of safety and efficacy of the drug product for use in

  Drug, Guidance, Clinical, Approval, Guidance on approval of clinical, New drug 3