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비즈니스 · 2015. 5. 19.1 분 읽기
List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations
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요약
The Food and Drug Administration (FDA) intends to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA's draft guidance for industry #230, "Compounding Animal Drugs from Bulk Drug Substances." You may nominate specific bulk drug substances for this list. This notice describes the information that should be provided to the Agency in support of each nomination.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →