FDA: Initiative to Vet Advertising of Newly Approved Products, the Launches…
Recently, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP), which was formerly the Division of…
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FDA Seeks Input on Device Classification System
Recently, the Food and Drug Administration (FDA) opened up a public comment period, extending to mid-January, to get perspective…
Physician Payment Sunshine: Senate Aging Committee Hearing Moved to…
Originally scheduled for December 7th Senate Special Committee on Aging Chairman Herb Kohl (D-Wis.) will convene a hearing on…
CMS Proposes Rules to Reduce Regulatory Burden on Hospitals
The Centers for Medicare & Medicaid Services (CMS) proposed new rules that would reduce unnecessary, obsolete, or burdensome…
FDA REMS to Promote Closer Ties to Healthcare Professionals
A recent article from the Food Drug Law Institute (FDLI) Update Magazine, discussed a recent session entitled “The Impact of…
Joslin Diabetes Center to Study Assessment Methodologies for CME Activities
The Joslin Diabetes Center, an affiliate of Harvard Medical School, announced the launch of a landmark research initiative to…
CMS Delays HIPAA Implementation by 90 Days
Recently, the Centers for Medicare & Medicaid Services (CMS) Office of E-Health Standards and Services (OESS) announced the…
The Park Doctrine and FDCA Violations: Holding Corporate Executives…
Over the past several months, the life sciences industry has been discussing a recent development in law enforcement: the…
HHS to Begin HIPAA Audits
Starting this month, healthcare organizations will be subject to audits by the Office of Civil Rights (OCR), evaluating their…
Physician Payment Sunshine Act: CMS Submits Regulations to OMB, Senate…
As we noted earlier this month, the Centers for Medicare and Medicaid Services (CMS) missed an October 1, 2011, mandatory deadline…