Tag: generic drug approval
Jun, 23 2026
FDA's 180-Day Exclusivity: Benefits for First Generic Applicants
Explore how FDA's 180-day exclusivity rewards first generic applicants, the risks of forfeiture, and proposed reforms like the CGT model to improve patient access.
May, 27 2026
Complex Generic Formulations: The Hidden Challenges in Proving Bioequivalence
Exploring the scientific and regulatory hurdles of complex generic formulations, including bioequivalence challenges, reverse engineering, and future solutions for patient access.
Nov, 27 2025
How the FDA Ensures Generic Drug Safety Through Manufacturing Oversight
The FDA ensures generic drug safety through strict manufacturing oversight, bioequivalence testing, global inspections, and continuous monitoring. Learn how generics meet the same standards as brand-name drugs.