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Review Phase Assessment for ANDA Submission in US: A Regulatory Review

Today, the vast majority of drugs available for patients in the United States are generics that have gone through a rigorous system of evaluation supervised by the United States Food and Drug Administration (FDA). Pachipulusu Rajesh, Dr. Balamuralidhara V and Dr. Gangadharappa H.V at the JSS College of Pharmacy demonstrate how to submit the ANDA application as per FDA requirements, and the review phase. They also present a discussion of ANDAs and NDAs, looking at their similarities and differences.