COVID-Fueled Reform At The FDA

One of the many lessons the biopharmaceutical industry has learned in the wake of the COVID-19 pandemic is that we can move fast. Really fast. Much faster than we ever thought possible.

While the speed and agility demonstrated in the race to develop COVID-19 vaccines and therapeutics was fueled by biopharmaceutical innovation, regulatory agencies have also exhibited an unprecedented ability to keep pace. The fruits of this collaborative effort between regulators and the regulated has evoked a collective sense of hope and optimism for the future of biopharma.

But will it last? Have the efficiencies, synergies, and collaborations forged over the past 16 months set new precedents for the way the FDA works, and new expectations on how biopharma companies work with the agency?

In this e-book, we’ve compiled recent assessments from the foremost FDA consultants and analysts in the space. Collectively, the insights they share shed light on the FDA’s go-forward strategy to maintain the regulatory tempo, while maintaining the stringent standards that have made it the world’s “gold standard” regulatory agency. We believe the insight shared in this collection of content will help biopharma leaders refresh their regulatory expectations and strategies as the industry returns to “normal,” embraces a new norm, or lands somewhere between the two.