On June 21, 2018, FDA issued new guidance related to the Prescription Drug User Fee Act. The document, titled Guidance for Industry: Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological...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
In recently issued draft guidance related to the implementation of product identifiers under the Drug Supply Chain Security Act ("DSCSA"), FDA has stated that it intends to exercise enforcement discretion for a period of one...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
5/22/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Domain Names ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more
The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more