In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy...more
1/24/2023
/ Advertising ,
Coronavirus/COVID-19 ,
Enforcement ,
False Advertising ,
Food and Drug Administration (FDA) ,
Marketing ,
Medical Devices ,
Misbranding ,
Misleading Statements ,
OPDP ,
Prescription Drugs ,
Sales Promotions ,
Warning Letters
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more
1/16/2023
/ Artificial Intelligence ,
Biotechnology ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Digital Health ,
Drug Distribution ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Investment ,
Machine Learning ,
Pharmaceutical Industry ,
Telemedicine
In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more
The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more