Myers A, Moore S R
Center for Drugs and Biologics, Food and Drug Administration, Rockville, MD 20857.
Drug Intell Clin Pharm. 1987 Oct;21(10):821-6. doi: 10.1177/106002808702101012.
By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A brief history on the legislation regarding the FDA's responsibility in the drug approval area is discussed along with recent regulations, legislation, and FDA initiatives aimed at improving the drug approval process. Specific information that can be released to the public upon request is also discussed. This paper is limited to the regulation of drugs; somewhat different regulations govern the review and regulation of biological products and abbreviated new drug applications.
根据法律规定，美国食品药品监督管理局（FDA）专员负责在一种新药被批准在美国上市之前确定其是否安全有效，并在批准后监测其使用情况。本文简要概述了审批流程，涉及申办者向FDA提交审评申请的职责以及FDA审评和批准这些申请的职责与组织程序。文中还讨论了FDA在药品审批领域职责的立法简史，以及近期旨在改进药品审批流程的法规、立法和FDA举措。此外，还讨论了应要求可向公众发布的具体信息。本文仅限于药品监管；生物制品和简略新药申请的审评与监管则遵循略有不同的规定。
