Zdrowie i gospodarka · 22/10/2021

FDA Releases Draft Guidance on Data Standards for Real-World Data in Drug Submissions

The Food and Drug Administration (FDA) has released a draft guidance for industry on data standards for drug and biological product submissions containing real-world data, aiming to support compliance with the Federal Food, Drug, and Cosmetic Act. This guidance is part of the FDA's efforts to evaluate the use of real-world evidence in regulatory decision-making.