On December 27, 2024, the United States Court of Appeals for the Second Circuit joined other federal circuit courts in adopting the “at-least-one-purpose” rule (generally shortened to the “one purpose rule”)....more
On April 21, 2020, the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) issued a Proposed Rule amending civil money penalty (CMP) regulations. This Proposed Rule seeks to address three...more
On April 10, 2020, the Department of Health and Human Services (DHHS) released the first $30 billion portion of the $100 billion stimulus fund intended to provide financial relief to healthcare providers during the COVID-19...more
On July 13, 2017, the Department of Justice, in conjunction with the Department of Health and Human Services, announced the largest series of health care charges in American history. The government charged 412 individuals,...more
On January 17, 2017, the Department of Health and Human Services (HHS) released a Final Rule announcing a three-prong appellate process change in an effort to decrease the growing Medicare appeals backlog at the...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more