Zdrowie i gospodarka · 28/12/2020

FDA Releases Final Guidance on Electronic Regulatory Submissions for Risk Evaluation and Mitigation Strategies Documents

The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry on providing regulatory submissions in electronic format, specifically for Risk Evaluation and Mitigation Strategies documents, in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance outlines the FDA's plan to implement electronic submissions for certain new drug applications, abbreviated new drug applications, and biologics license applications, starting December 28, 2022.