Zdrowie i gospodarka · 29/12/2016

Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability

The US Food and Drug Administration (FDA) has released a draft guidance outlining its policy on compounding and repackaging of radiopharmaceuticals by outsourcing facilities. The guidance explains how the FDA will apply a specific section of the Federal Food, Drug, and Cosmetic Act to these activities.