Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs -
On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule...more
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more
12/14/2016
/ Ambulance Providers ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Cost-Sharing ,
Deductibles ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Life Sciences ,
OIG ,
Pharmacies ,
Remuneration ,
Safe Harbors
FDA issued a Form FDA 483 to fifteen prominent hospitals across the United States following inspections that demonstrated failures to comply with the user facility medical device reporting requirements pursuant to 21 C.F.R....more
On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more
10/27/2016
/ Adverse Events ,
Civil Monetary Penalty ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Good Cause ,
Medical Devices ,
Penalties ,
Pharmaceutical Industry ,
Public Access Laws ,
Public Health Service Act