On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more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 April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
5/1/2024
/ Compliance ,
Enforcement ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Labeling ,
Medical Devices ,
Misleading Statements ,
Premarket Approval Applications ,
Proposed Rules ,
Public Health
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
On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more
10/27/2016
/ Adverse Events ,
Civil Monetary Penalty ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Good Cause ,
Medical Devices ,
Penalties ,
Pharmaceutical Industry ,
Public Access Laws ,
Public Health Service Act