A guide to PDUFA V

Article from TOPRA,  Regulatory Rapporteur – Vol 9, No 11, November 2012. 

Authors

Virginia Beakes-Read JD RN, Executive Director, Global 

Regulatory Policy and Intelligence, Eisai, Inc; 

Florence Houn 

MD MPH FACP, Vice President, Regulatory Policy and Strategy, Celgene Corporation;

Andrea Masciale JD, Vice President, Global Regulatory Policy and Intelligence, Janssen Pharmaceutical Companies of Johnson & Johnson; 

Kim Quaintance, Senior Director, Global Regulatory Policy and Intelligence, Eisai, Inc.

This article highlights important new programmes in the reauthorised Prescription Drug User Fee Act (PDUFA) which came into force on 1 October 2012. To facilitate future reference, we have provided tools such as a timeline of key events and descriptions of the critical aspects of the new review programme. Also included is a question-and-answer section, addressing issues that regulatory affairs professionals are likely to face, and providing some solutions and recommendations. Finally, the article summarises the FDA’s commitments, which include enhanced communication during drug development; advancing the science of meta-analysis methodologies; aiding the development of endpoint assessment tools; improving benefit–risk assessment in regulatory decision-making; standardising risk evaluation and mitigation strategies (REMS); modernising pharmacovigilance processes and enhancing drug safety information systems and infrastructures.

Reference: A guide to PDUFA V

Current hot topics for regulatory professionals

Article from TOPRA,  Regulatory Rapporteur – Vol 9, No 11, November 2012. 

Authors

Patricia Duchêne, Director Regulatory Affairs, Celgene Corporation, US; Monique Garrett, CEO, PrismWorks, LLC; 

Sara Snow, Senior Associate II, Regulatory Development, Biogen Idec

This article represents views of senior US regulatory leaders on current hot topics for regulatory professionals.

• What is the biggest challenge you see facing the US regulatory affairs community in the coming year? 
• Are you witnessing any new trends in the regulatory affairs arena that you think will impact approval processes in the US? 
• How do you think agency/sponsor relations will change in the coming year?
• Do you have any advice for regulatory professionals who may be planning on submitting in the US?

Reference: All in a day’s work