Deze vertaling wordt voorbereid. Voorlopig tonen we de oorspronkelijke Engelse versie.
Bedrijven · 4-2-20001 min lezen
Draft Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availability
Lokale automatische vertaling · Oorspronkelijke brontaal
Samenvatting
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information." This draft guidance provides recommendations to industry on formal meetings between sponsors of investigational new drug applications (IND's) and the Center for Drug Evaluation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.
Oorspronkelijke brontaal: Federal Register — Food and Drug AdministrationOrigineel bericht openen →