Zdrowie i gospodarka · 27/01/2022

FDA Releases Final Guidance on Information Requests and Discipline Review Letters Under GDUFA

The Food and Drug Administration (FDA) has released a final guidance document outlining the process for issuing information requests and discipline review letters during the review of original abbreviated new drug applications (ANDAs) under the Federal Food, Drug, and Cosmetic Act. This guidance finalizes a previously released draft from December 18, 2017.