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Entreprise · 04/02/20001 min de lecture
Draft Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information." This draft guidance provides recommendations to industry on formal meetings between sponsors of investigational new drug applications (IND's) and the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) on chemistry, manufacturing, and controls (CMC) information.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →