ビジネス · 2012/4/111 分で読めます
Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; 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 guidance entitled "Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs." This guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.