10.29.20 -- Is Biopharma Suffering From Thalassophobia?

As an FDA regulator explored in a recent presentation, biopharmaceutical manufacturing innovation has not kept pace with R&D. He shared several thoughts on why this may be the case, offering a call to action for the industry to reevaluate its notions of value to encourage greater manufacturing innovation.

Most FDA guidance on COVID-19 has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologics manufacturers, whether or not they produce COVID-19-related products.