On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more
2/2/2017
/ Administrative Authority ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Life Sciences ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry
The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more
4/22/2016
/ Administrative Authority ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Exclusion Orders ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Fraud and Abuse ,
New Guidance ,
OIG ,
Risk Assessment ,
Willful Misconduct