Generic and branded drug manufacturers may soon have long-awaited answers from the Supreme Court regarding skinny labeling practices. On January 16, the Supreme Court granted a generic company certiorari in Amarin Inc. v....more
1/22/2026
/ Abbreviated New Drug Application (ANDA) ,
Certiorari ,
Generic Drugs ,
Hatch-Waxman ,
Induced Infringement ,
Labeling ,
Motion to Dismiss ,
Off-Label Promotion ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS
Since the U.S. House of Representatives passed the Clarity Act on July 17, the U.S. Senate Committee on Banking, Housing and Urban Affairs, which has oversight of the U.S. Securities and Exchange Commission, has been busy...more
12/15/2025
/ Anti-Money Laundering ,
Banking Sector ,
CFTC ,
Cryptocurrency ,
Digital Assets ,
Disclosure Requirements ,
New Legislation ,
Popular ,
Proposed Legislation ,
Regulatory Oversight ,
Regulatory Reform ,
Securities and Exchange Commission (SEC) ,
Senate Banking Committee
The Supreme Court may soon address a recent, pivotal case involving the use of “skinny labels” to avoid inducing infringement in pharmaceutical patent infringement cases. The outcome could clarify whether and how generic drug...more
9/26/2025
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Induced Infringement ,
Intellectual Property Protection ,
Labeling ,
Life Sciences ,
Manufacturers ,
Marketing ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product Labels
Since the House passed the CLARITY Act on July 17, the U.S. Senate Banking Committee, which has oversight of the Securities and Exchange Commission (SEC), has been busy working on its own version of the U.S. crypto regulatory...more
8/5/2025
/ Ancillary Agreements ,
Anti-Money Laundering ,
Blockchain ,
BSA/AML ,
CFTC ,
Cryptoassets ,
Digital Assets ,
Investment ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform ,
Rulemaking Process ,
Securities and Exchange Commission (SEC) ,
Securities Regulation ,
Senate Banking Committee
Cosmetics Regulation -
Currently, cosmetics are regulated through the Federal Food, Drug, and Cosmetic Act (FDCA)– which has recently been revamped by the Modernization of Cosmetics Regulation Act (MoCRA)–and various...more
California has become the first U.S. state to ban the use of four potentially harmful food and drink additives. On October 7, 2023, Governor Gavin Newsom signed into law California Assembly Bill 418, the California Food...more