Perspectives

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.

On June 1, 2020, the FDA released a statement notifying the public that they have taken additional steps to increase the supply of alcohol-based hand sanitizer during the ongoing COVID-19 pandemic.

COVID-19 is disrupting working life as we all know it. In the context of the annual brand planning cycle, we caught up with Jane Ayton and Peter Smith, two of our Senior Vice Presidents at Cello Health Consulting, to get their view of the challenges ahead.