Understanding ANDA Submission Requirements: A Key to Affordable Medicine
Understanding ANDA Submission Requirements: A Key to Affordable Medicines 🔍 What is an ANDA? An Abbreviated New Drug Application (ANDA) is a submission to the U.S. Food and Drug Administration (FDA) to gain approval for a generic drug. Unlike a New Drug Application (NDA), which requires extensive preclinical and clinical data to prove safety and…