In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more
In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more
In the News. The Securities and Exchange Commission (SEC) announced that it adopted Rule 12d1-4 under the Investment Company Act of 1940 (the 1940 Act), providing a new regulatory framework for fund-of-funds and final...more
Q4 Update: Overview of Cartel Investigations - Although 2018 saw guilty pleas and new indictments in several ongoing Department of Justice (DOJ) investigations, the year finished by continuing a downward trend in antitrust...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Rapid Growth of Influencer Marketing - With more consumers cutting the cord to their TVs and paying for premium subscriptions or ad blockers to avoid advertising, social media has become an important medium through which...more