Tag: FDA Orange Book
Pediatric Exclusivity: How the FDA Extends Drug Market Protection Without Changing Patents
Pediatric exclusivity gives drugmakers six extra months of market protection by blocking generic approvals-even after patents expire. It's not a patent extension, but it's just as powerful.
Continuing Education for Pharmacists: Staying Current on Generics
Pharmacists must stay current on generics to avoid dangerous substitution errors. With 90% of prescriptions filled with generics and constantly changing FDA ratings, continuing education isn't optional-it's essential for patient safety and legal compliance.