FDA Using Accountability to Deter Illegal Marketing Activity
Using accountability as a tool to deter illegal activity like misbranding and promote corporate transparency was a resounding…
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February 2012
FDA CDRH – MDUFA Agreement and Strategic Priorities for 2012
The FDA and industry recently came to an agreement in principle for the Medical Device User Fee Act (MDUFA), costing the device…
Physician Payment Sunshine Act: CMS Proposed Rule – Links to Legal…
The February 17th deadline is quickly approaching for individuals and stakeholders to submit comments for the proposed regulations…
Hospitals Hire Sales Reps to Recruit Referrals
Typically, when we think of sales representatives, we see the image of a man or woman dressed in a suit, entering a doctor’s…
Convergence of Interest – Not Conflict of Interest
Given all the recent coverage of the proposed regulations implementing the Physician Payments Sunshine Act (Section 6002 of the…
Physicians Face Cash Crunch – New Payment Models May not Work for Many…
According to a recent article from CNN Money, “many doctors are going broke,” creating a “quiet reality that is spreading…
Independent Payment Advisory Board May Be Much Further Off Than Originally…
One of the major issues with the Affordable Care Act (ACA) is the repeal of the Independent Payment Advisory Board (IPAB),…
HHS Adoption of Standards for Health Care Electronic Funds
The U.S. Department of Health & Human Services (HHS) released a rule that adopts streamlined standards for the format and data…
HHS OIG Annual Solicitation For Safe Harbors
On December 29, 2011, the Office of Inspector General of the Department of Health and Human Services ("OIG") published its annual…
FDA Quantitative Summary of the Benefits and Risks of Prescription Drugs: A…
The Food and Drug Administration (FDA) recently announced the availability of a draft report entitled “Quantitative Summary of the…