Zdrowie i gospodarka · 20.09.2005
Draft Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "PET Drug Products--Current Good Manufacturing Practice (CGMP)." Elsewhere in this issue of the Federal Register, we are issuing proposed regulations on CGMPs for positron emission tomography (PET) drug products. We are making the draft guidance available so that producers of PET drugs can better understand FDA's thinking on CGMP compliance if the proposed regulations become final after notice-and-comment rulemaking.