The Pink Sheet | COVID-19 Vaccines: FDA’s Broad Authority to Craft Narrow EUAs May Push Agency Out of Its Comfort Zone

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

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.

Cathy Burgess comments on U.S. Food and Drug Administration requirements for the timely reporting of pharmaceutical data integrity concerns in preclinical and clinical research.

Cathy Burgess is referenced for commenting at a Food and Drug Law Institute conference on the timing for declaring a drug manufacturing facility as “official action indicated” following inspection by the U.S. Food and Drug Administration.