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 United States Food and Drug Administration (FDA) plays a crucial role in regulating the…
Navigating Refuse to Receive (RTR) Standards: Key Insights for Successful ANDA Submissions
The Refuse to Receive (RTR) standards play a critical role in the ANDA (Abbreviated New…
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
Introduction The Common Technical Document, CTD is a globally recognized format for the submission of…
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…
