Discover how Paragraph IV certification enables generic drugs to challenge brand-name patents under the Hatch-Waxman Act. Learn about the 30-month stay, 180-day exclusivity rewards, and the legal strategies shaping pharmaceutical competition.
Explore the legal and regulatory requirements of the ANDA process for generic drug approval. Learn about Hatch-Waxman, bioequivalence, patent certifications, and FDA fees.
Explore the major legal and regulatory shifts of 2025-2026, from California's labor and housing reforms to federal tax changes and the impacts of the 119th Congress.