Category: Pharmaceutical Technology
Discover how the FDA monitors drugs entering the US through its five-phase import inspection process. Learn about risk-based targeting, the end of de minimis exemptions, and how to avoid shipment detention.
Discover why effective patent life is shorter than the standard 20-year term. Learn how R&D timelines, the Hatch-Waxman Act, and evergreening strategies impact drug market exclusivity and generic competition.
Explore the complex challenges of proving bioequivalence for combination products, from FDC interactions to drug-device user interface hurdles and regulatory traps.
Explore how blockchain technology is eliminating counterfeit medicines and securing the generic drug supply chain through immutable digital pedigrees and DSCSA compliance.