ISO 9000. Policy implications for FDA. Taking the pulse of increasing global use of the ISO series of uniform quality standards by FDA regulated industries.
Schwemer
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WL
Office of Policy, United States Food and Drug Administration, Rockville, Maryland.
Lynch
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MA
D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D007391:International Cooperation; D007564:Japan; D007880:Legislation, Drug; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards*