CMS Adds $200 Million In Payments to Open Payments Database
On Friday, the Centers for Medicare and Medicaid Services (CMS) added approximately 68,000 payment records—valued at more than…
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A Year After Making Big Changes To Sales Practices, GSK Cuts R&D In…
GlaxoSmithKline’s 2012 Corporate Integrity Agreement made mandatory the company’s policy that it would not provide sales reps with…
OIG Plans Review of FDA’s Regulatory Activity, According to New Work Plan
OIG Plans to Focus on How FDA Inspects Generic Manufacturers and Enforces Postmarketing and Clinical Trial Transparency…
“E 4 Ethics”: EFPIA Offers Pre-Assessment of Educational Events…
The focal point of the EFPIA HCP Code provisions on scientific or educational meetings and conferences is…
Physician Payments Sunshine Act: CMS Releases Continuing Medical Education…
Yesterday, the Centers for Medicare and Medicaid Services (CMS) issued three FAQs and an example grid to supplement…
OIG Issues 2015 Work Plan
The Department of Health and Human Services Office of Inspector General recently released its 2015 Work Plan. OIG’s…
NIH Launches “ClinRegs” Website Aggregating Country-By-Country…
The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched an online…
Former Sanofi Paralegal Brings $34 Million Whistleblower Lawsuit
A paralegal recently fired by French drug manufacturer Sanofi has filed a whistleblower lawsuit, claiming she was discharged after…
New Bill Would Exempt Low-Risk Medical Software and Apps from FDA…
Bipartisan legislation drafted by Senators Orrin Hatch (R-Utah) and Michael Bennett (D-Colo.) looks to exempt electronic health…
FDA Combination Product Classification Again Struck Down By D.C. Court
Whether the FDA considers a product to be a “medical device” as opposed to a “drug” has very important implications.…