On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more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
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
Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more
2/9/2022
/ Clinical Trials ,
Data Privacy ,
Deadlines ,
Disclosure Requirements ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
New Regulations ,
Proposed Regulation ,
Reporting Requirements ,
UK