Compliance Officers as Chief Data Analyst
With the US Sunshine reporting data fast approaching March 31, compliance teams are heads down in getting the spend records…
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March 2016
New Canadian CME Standards for Commercial Support
Canada has created new standards for industry involvement with accredited CME programs. Three professional…
Senate Introduces Bill Eliminating the Tax Deduction for DTC Advertising
Four Democrats have introduced a Senate companion bill to the House bill to ban nearly all direct-to-consumer (DTC)…
Office of the National Coordinator for Health Information Technology…
The United States Department of Health and Human Services released a proposed rule last week that would permit the…
FDA National Direct to Consumer Advertising Survey – Again
If at first you don't succeed try, try again. That seems to be the theme of a recent announcement by the Food and Drug…
PDFUA-MDUFA Update March 2016
Last year, the U.S. Food and Drug administration kicked off the reauthorization process for MDUFA, or the Medical Device…
CMS Opens Physician and Teaching Hospital Registration for Open Payments…
CMS has announced that the Open Payments system is now open for physician and teaching hospital registration. While…
Biogen Joins the Center for Therapeutic Target Validation
The Center for Therapeutic Target Validation (CTTV) has a new member to boast about, helping them improve the success…
CMS Proposed Rule Drastically Changes the Way Medicare Pays for Part B…
The Centers for Medicare and Medicaid Services announced their proposal to test new Medicare Part B prescription drug…
Amarin and FDA Off Label Free Speech Settlement
The United States Food and Drug Administration (FDA) and Amarin announced that they have reached a proposed settlement…