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Living With the Two Big C’s: Cancer Patients and the COVID-19 Pandemic
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.
View Aug 4, 2020
NDA Versus OTC Monograph: Which Pathway is Right for You?
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.
View Jun 22, 2020