An Unbiased View of Abbreviated New Drug Application (ANDA)
It does not demand preclinical and clinical trials but will have to show bioequivalence by bioavailability and bioequivalence studies. The ANDA contents and assessment procedure are outlined based on the Popular Technical Doc format in five high quality, nonclinical, and medical modules.TIFAC is an autonomous Firm arrange in 1988 underneath the Sec