On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
11/17/2023
/ Chief Compliance Officers ,
Compliance ,
Corporate Integrity Agreement ,
Disclosure Requirements ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infrastructure ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Policies and Procedures ,
Risk Assessment
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
In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription...more