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비즈니스 · 2002. 8. 21.1 분 읽기
Draft Guidance for Industry on Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Availability
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요약
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation." This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); human pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs).
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →