ANDAs: Pre-Submission Facility Correspondence (PFC) Associated with Priority Submissions
Introduction The Abbreviated New Drug Application (ANDA) is a vital pathway for the approval of…
Types of Applications for Drugs and Biologics in U.S
The FDA regulates the approval and marketing of drugs, biologics, and other products in the…
Navigating Refuse to Receive (RTR) Standards: Key Insights for Successful ANDA Submissions
The Refuse to Receive (RTR) standards are vital for the ANDA submission process, determining regulatory…
Master the Bioequivalence study report – Key Insights to interpret a BE Report
Introduction A Bioequivalence (BE) Study Report is a comprehensive document that outlines the findings and…
Controlled Correspondence: A Key Strategy in Generic Drug Development
Introduction: In the world of pharmaceutical manufacturing and regulation, generic drugs play an important role…
Types of Exclusivities and Incentive Periods by Global Health Authorities
Exclusivity: Exclusivity is exclusive marketing rights granted by the Health Authority upon approval of a…