Perspectives

This episode of Medical Affairs Unscripted features Randi Goeckeler, an industry expert with over 25 years of experience and most recently the Executive Director of Global Stakeholder Relations at Allergan.

We are in uncharted territory. The full impact of the COVID -19 pandemic has yet to be realised. No one quite knows what the ‘new normal’ will look like or, importantly, when it will come about. But the vital role of healthcare services, Pharma and research is central to recovering from the pandemic.

On Wednesday July 8, 2020, Dr. David Schwartz presented at the IADC 2020 Virtual Annual Meeting on a panel titled The Use of Genetic Testing in the Courtroom. A complimentary copy of the panel presentation is now available for download.

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market.