On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more
12/20/2022
/ Citations ,
Draft Guidance ,
FDARA ,
FDASIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Medical Devices ,
OSHA ,
Pharmaceutical Industry ,
Prescription Drugs
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
12/14/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Data Integrity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry