On Wednesday, in a 2-1 decision, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit ruled in Jarkesy v. SEC that proceedings before an SEC administrative law judge were unconstitutional. Notably, the...more
On December 15, 2021, the Securities and Exchange Commission proposed amendments to Rule 10b5-1 under the Securities Exchange Act of 1934, which provides a safe harbor and affirmative defense from insider trading for...more
This week, SEC Chair Gary Gensler identified Rule 10b5-1 stock trading plans and equity trading rules as fresh areas of regulatory focus for the SEC. Gensler mentioned these areas during prepared remarks at the CFO Network...more
On March 31, 2021, the SEC’s Division of Corporation Finance and Acting Chief Accountant issued separate public statements concerning Special Purpose Acquisition Companies (“SPACs”). In these recent statements, the SEC is...more
The unprecedented challenges created by the COVID-19 pandemic and resulting government lockdowns could strain even the most robust compliance programs. Companies have been appropriately focused on business preservation during...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS