IND

Interim New Drug – A submission to the FDA that discloses the manufacturing procedure and all required testing. FDA reviews IND’s in 30-60 days.

NCTR

National Center for Toxicological Research

NDA or ANDA

New Drug Application – Required prior to offering a new drug to market Abbreviated New Drug Application – Used for the submission of a generic drug application to the FDA

Validation

Confirming that the outcome is repeatable and is what as expected.