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…
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…
Mastering the CTD: Harmonized and Regulatory Data Submissions
The Common Technical Document (CTD) is an internationally accepted format for drug applications, created by…
Types of Market Exclusivities and Implications on Forfeiture
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors:…
The Hatch-Waxman Act : Balancing Drug Patents and Generic Entry
Introduction Every new drug must prove to be safe and effective to be approved by…
