In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S....more
8/15/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Rulemaking Process ,
SCOTUS ,
Trump v CASA
In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more
A recent development with the Food and Drug Administration made us think of a song lyric from Florida native and Rock and Roll Hall of Famer, Tom Petty, “What lies ahead, [we] have no way of knowing.” As a kick-off to 2024,...more
On November 20, 2020, the United States Department of Health and Human Services (HHS) issued a Federal Register notice to: (1) withdraw the Food and Drug Administration’s (FDA) Compliance Policy Guide (CPG) Sec. 440.100...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 and highlights articles from members of AGG outside the Food and Drug practice....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
1/26/2018
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
CGMP ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Pricing ,
False Claims Act (FCA) ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Human Resources Professionals ,
OCR ,
PHRMA
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
4/22/2016
/ Abbott Laboratories ,
All Natural ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Investors ,
Medicare Part B ,
Misleading Impressions ,
Natural Products ,
Personal Care Products ,
Pharmaceutical Industry ,
Prescription Drugs ,
Securities and Exchange Commission (SEC) ,
Securities Fraud