Zdrowie i gospodarka · 29/06/2010
Change of Address; Abbreviated New Drug Applications; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit abbreviated new drug applications (ANDAs) and ANDA amendments, supplements, and resubmissions. FDA is also updating the address for ANDA applicants to submit investigational new drug applications (INDs) for in vivo bioavailability and bioequivalence studies in humans that are intended to support ANDAs. This action is being taken to ensure accuracy and clarity in the agency's regulations.