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 responsibility of delivering quality medicines to the population. Our experts elaborate on the subdivisions and their responsibilities toward the safety and efficacy of medications.

To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry  

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 verification of Intellectual Proprietary Rights. Our experts enlist various exclusivity periods stated under different designations and more.

To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry 

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) Breakthrough Therapy, (iii) Accelerated Approval, and (iv) Priority Review and their impact on drug development timelines.

To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry 

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 phase to the FDA review.

To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry 

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.

To know more about Season 3, visit https://www.freyrsolutions.com/regulatory-radio/season-3-us-market-entry 

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. 

The pharmaceutical advertising in Canada for prescription drugs has always been under scrutiny as laws governing Direct-to-Consumer (DTC) advertisements of prescription-only medicines are misunderstood by organizations. The governing authority for medicines, Health Canada, is responsible for general advertisement and promotions. Our host highlights the laws and regulations laid down by Health Canada.   

Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions

The Mexican pharmaceutical promotional regulations for advertising drugs, governed by the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), are subjected to specific requirements to protect Healthcare Professionals (HCPs) and consumers from any associated risks. In this episode, our host describes the general requirements of drugs from an advertising perspective, legislated and issued by the Code of Conduct. 

Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions

Post-Brexit, the United Kingdom’s advertising review team scrutinizes published advertising in selected media, and we investigate referrals from colleagues in the Agency or other Regulatory Authorities. Our host addresses the necessary pharmaceutical advertising regulations a pharmaceutical organization must follow to ensure that the advertising material is thoroughly reviewed before the issue, thus avoiding misleading messages and protecting consumers from any potential negative impact.

Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions

The Republic of Lithuania reflects good economic fortune for medicine manufacturers’ regional investments. To explore the Lithuanian market, manufacturers must obtain approvals from the State Medicines Control Agency. Our host gives us an insight into the Regulatory framework involved in the successful advertising and promotion of medicines.

Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions