Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.
D000818:Animals; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D014481:United States; D014486:United States Food and Drug Administration