Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications -
On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products –...more
The U.S. Federal Trade Commission (“FTC” or “the Commission”) maintains Guides Concerning Use of Endorsements and Testimonials in Advertising to “set forth the general principles that the Commission will use in evaluating...more
8/11/2023
/ Advertising ,
Advertising to Minors ,
Celebrity Endorsements ,
Code of Federal Regulations (CFR) ,
Disclosure Requirements ,
Endorsements ,
Federal Trade Commission (FTC) ,
FTC Act ,
FTC Endorsement Guidelines ,
Influencers ,
Marketing ,
Online Endorsements ,
Social Media ,
Unfair or Deceptive Trade Practices
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