ビジネス · 2012/2/271 分で読めます
Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "FDA Oversight of PET Drug Products--Questions and Answers." The draft guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.