Changes to Regulations 21CFR312 & 21CFR314:

Change of address for submissions.

21CFR312 - Update to the address for ANDA applicants to submit IND’s for in vivo bioavailability and bioequivalence studies that are intended to support ANDA’s

21CFR314 - Updates to the address for applicants to submit ANDA’s and ANDA amendments, supplements and resubmissions.