[Webinar] EHS in the Cannabis Industry: What Happens When the E stands for Enforcement?
Pamela Para on Effective Investigations in Healthcare
Susan Roberts on Creating a Compliance Program Book
Reasonable minds can differ
Compliance Perspectives: Risk and the 2020 Compliance & Ethics Institute
How to Assess the Likelihood of Success in Deciding Whether to Bring a Bid Protest
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more
On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and...more
Report on Research Compliance Volume 20, Number 3. February 23, 2023 - The Office of Management and Budget (OMB) is planning to revise the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for...more
Report on Research Compliance Volume 19, Number 9 (September, 2022) - According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los...more
On September 21, 2020, the HHS Office of Civil Rights (OCR) announced a $1.5 million settlement with Athens Orthopedic Clinic, a Georgia orthopedic clinic, to settle potential violations of the Health Insurance Portability...more
The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...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