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
Arnall Golden Gregory LLP's 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 Washington, DC...more
Arnall Golden Gregory LLP's 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 Washington, DC...more
8/18/2017
/ Cosmetics ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent...more
Arnall Golden Gregory LLP's 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 Washington, DC...more
8/23/2016
/ 510(k) RTA ,
Advertising ,
Draft Guidance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
LabMD ,
Medical Devices ,
Pharmaceutical Industry ,
Social Media ,
Software
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