FDA Revises Foreign and Domestic Establishment Registration Requirements for Human Drugs (September 2016)The Food and Drug Administration (FDA) is issuing a final rule regarding the registration of drug establishments and listing of human drugs. FDA hopes this rule will help modernize existing regulations in response to changes made under Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C).
FDA is updating the text to more clearly define terms used and clarify rules regarding who must register and how they should register. Additionally, the final rule requires that registration and drug listing submissions be done electronically. With this rule, FDA aims to make the registration process more efficient for both the agency and suppliers.
|Requirements for Foreign and Domestic Establishment Registration and Listing|