On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
11/17/2023
/ Chief Compliance Officers ,
Compliance ,
Corporate Integrity Agreement ,
Disclosure Requirements ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infrastructure ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Policies and Procedures ,
Risk Assessment
On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more
3/2/2022
/ Australia ,
Canada ,
EU ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inspections ,
International Standards ,
Japan ,
Medical Devices ,
Proposed Regulation ,
Proposed Rules