Draft Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information." This draft guidance provides recommendations to industry on formal meetings between sponsors of investigational new drug applications (IND's) and the Center for Drug Evaluation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.