FDA Submits to Congress User Fee Act Recommendations
The U.S. Food and Drug Administration (FDA) last week announced that it had completed its recommendations for three user fee…
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January 2012
FDA: Transmucosal Immediate-release Fentanyl (TIRF) REMS
The Food and Drug Administration (FDA) recently approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the…
ACCME Roundup January 2012, CME Providers Improving in Compliance
The Accreditation Council for Continuing Medical education (ACCME) recently released the executive summary of its Board…
FDA Medication Guides – Distribution Requirements and Inclusion in Risk…
The Offices of Regulatory Policy, Medical Policy, Surveillance and Epidemiology, New Drugs, Compliance, and Generic Drugs in the…
AHRQ Unintended Consequences Guide for Electronic Health Records
A new online guide is available from the U.S. Agency for Healthcare Research and Quality (AHRQ) to help hospitals and other health…
Twelve Enforcement and Compliance Predictions for 2012
A recent blog post from Health Care Enforcement & Compliance Matters discussed 12 Enforcement and Compliance predictions for…
Lupus Education Initiative Funded in 2012 Appropriations
Legislation signed by White House addressed Early Lupus Diagnosis and Treatment. A top legislative priority of the Lupus Research…
CMS Selects 32 Pioneer Accountable Care Organizations
The Centers for Medicare & Medicaid Services (CMS) announced the final list of 32 Pioneer Accountable Care Organizations (ACO)…
FDA Guidance Responding to Unsolicited Request for Off-Label Information…
Recently, the Food and Drug Administration (FDA) released a Guidance for Industry, entitled “Responding to Unsolicited Requests…
CMS and OMB Announce New Fraud Measures
In 2010, the President announced three goals for cutting improper payments in federal health programs by 2012: reducing overall…