The Pink Sheet | Data Integrity ‘More than Just a GMP Issue’ As Attention to Clinical, Nonclinical Lapses Grows

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

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 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.

Cathy Burgess comments on whether the U.S. Food and Drug Administration will clarify the Park Doctrine, which allows the government to seek misdemeanor convictions against company officials for alleged violations of the Federal Food, Drug, and Cosmetic Act.

Cathy Burgess is quoted about the impact that warning letters from the U.S. Food and Drug Administration can have on a manufacturer's operations and reputation.