Zdrowie i gospodarka · 01/04/2002
Draft Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "PET Drug Products--Current Good Manufacturing Practice (CGMP)." We are announcing the availability of preliminary draft proposed regulations elsewhere in this issue of the Federal Register. We are making the draft guidance available so that producers of positron emission tomography (PET) drugs will better understand FDA's thinking concerning CGMP compliance if the preliminary draft proposed regulations were to become final after notice and comment rulemaking.