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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Potential Consequences of SARS-CoV-2 to ongoing clinical programs

In this white paper, NDA’s Dr Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.

Enhancing Pharmacovigilance

This article discusses the tremendous expansion in oncology products with great opportunities that will benefit patients.

Have you ever wondered why compliance with regulations is so difficult?

What do we mean when we say ‘safety is everybody’s responsibility’? What is meant by risk-based compliance? What is the basis for an effective safety system?

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.