The Pink Sheet | US FDA Getting Faster at Notifying Drug Facility Owners of Inspection Status

The Food and Drug Law Institute (FDLI) has named Cathy Burgess, partner at Alston & Bird and co-leader of the firm’s FDA/Food, Drug & Device Team, a recipient of the FDLI 2023 Distinguished Service and Leadership Award. The annual award recognizes individuals who have made notable contributions to the food and drug law community through their leadership.

Cathy Burgess is quoted on COVID-19 safety considerations for Food and Drug Administration inspections.

Cathy Burgess is quoted on the potential impact of the U.S. Food and Drug Administration’s plan to tailor an emergency use authorization to a COVID-19 vaccine.

Cathy Burgess is quoted on how the U.S. FDA’s Center for Drug Evaluation and Research could potentially handle the expiration of COVID-19-related emergency use authorizations it has issued for drug products.

Cathy Burgess is quoted on how the U.S. Food and Drug Administration may relax its stance on re-inspection of facilities receiving Official Action Indicated notices due to the coronavirus pandemic.