On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more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 June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more
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 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more
Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons -
On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more
2/10/2020
/ Anti-Competitive ,
Biologics ,
Biosimilars ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Labeling ,
Misleading Statements ,
Prescription Drugs ,
Public Comment
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors -
On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
6/21/2018
/ Final Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Labeling ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Required Communications ,
Safe Harbors
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