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It does not need preclinical and clinical trials but must reveal bioequivalence by way of bioavailability and bioequivalence scientific studies. The ANDA contents and review system are outlined according to the Prevalent Technical Doc structure in five good quality, nonclinical, and medical modules.An adverse celebration or suspected adverse respon
It doesn't have to have preclinical and medical trials but will have to demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review approach are outlined based on the Prevalent Technical Doc format in five quality, nonclinical, and medical modules.The sponsor shall submit an exact and comprehensive En