Thought Leadership

At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.

We call it Thought Leadership.

Articles and White Papers



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Rare Diseases and FDA Advisory Committees: Be the Experts in the Room

NDAs Neelu Agrawal describes the unique challenges, along with key factors for success when preparing for an advisory committee for a rare disease.

Novel Drug Movers and Shakers 2013-2016

Small and medium sized companies and academia are important drivers of innovation in drug development. To investigate the profile of the organisations originating and developing novel drugs approved in the EU and US during 2013-2016 we have compiled all...

The Premiere edition of Translational Science of Rare Diseases

The journal will feature independent, original research articles as well as in-depth review of specific rare diseases and therapeutics, and opinion pieces from regulators, patient advocates and leading industry and academic researchers focused on rare d...