Part 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
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Drugs Overview of Hatch-Waxman and reforms 30-month stay; patent extensions; ANDA filer exclusivity (180 day) Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes Reviewing fundamentals of applications Exploring the ANDA Paragraph IV Certification, and response to Notice Letters Examining ANDA Standards for approval and the concepts of sameness and bioequivalence…