Freyr Regulatory Radio

Introduction to the USFDA framework and the cascade of events ultimately lead to authorization to market a drug product. Our experts elaborate on every department under the US FDA, focusing on the CBER and the CDER.

Establishment of the GDUFA and PDUFA guidelines and their impact on innovators and generics. Our experts discuss various merits of the guidelines and the significant changes signed into the law with each latest amendment.

Understanding the unique benefits of standard drug approval pathways by the US FDA. Our experts talk about the importance of the different stages of drug development, right from the drug discovery/conceptual phase, pre-clinical phase, and clinical ph...

Expedited drug development pathways ensure the availability of treatment at the earliest. The US FDA’s facilitated Regulatory pathways give priority to innovators based on the nature of their innovation and more. Our experts discuss (i) Fastrack, (ii...

Patents are non-tangible assets for an organization/individual. To safeguard the innovator’s rights, the US FDA follows a unique patenting pathway for innovations. The United States Patent and Trademark Office (USPTO) looks after the awarding and ver...

The Regulatory Affairs Life Cycle Management of a drug is considerably different from other commodities. The Office of the Lifecycle of Drug Products, a department under the Office of Pharmaceutical Quality (OPQ) under CDER, oversees the responsibili...