New FDA Guidance: Impact on Clinical Safety Data

As the FDA continues to tighten legislation around suspected adverse events, it becomes more important than ever to stay fully up-to-date with all the obligations and requirements. This article written by NDA’s Brian Edwards and Olga Björklund explains the best way to stay compliant.

The article is published in International Clinical Trials August 2016, pages 28-29. © Samedan Ltd. ICT is a specialist journal designed to provide global coverage of key topics pertinent to the clinical trials sector.







Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group





Olga Björklund, PhD Senior Consultant, NDA Group