Legal / Regulatory
Drug shortages continue to challenge health systems
More compounding pharmacy recalls worsen the situation; FDA looks for new legislation
Will crowd-sourced online search data become a better 'sentinel' for adverse event reporting?
Academic study finds evidence of an early warning system in anonymized Web searches
 
Lessons learned on bona fide service fees and fair market value-is there a 'right answer'?
Recent regulatory actions and court cases highlight the importance of due diligence in reporting the value of service fees when federal reimbursements are concerned. The financial consequences can be substantial
Criminal investigations for counterfeit, diverted drugs skyrocketed in 2012
Number of cases opened by FDA's Office of Criminal Investigations (OCI) triples to 170
Who will represent the specialty pharmacy business?
As the business grows at double-digit rates, representing its interests becomes its own business opportunity
VALID Compounding Act to regulate compounding pharmacies is introduced
A new policy debate over drug regulation is emerging as the NECC scandal worsens
 
In an EHR era, adverse event reporting takes on a new look
As the number of adverse events (AEs) grows year by year, regulators and industry managers are looking at automated systems to handle the burden
 
Analyzing drug-pricing mechanisms
Pricing systems in US drug supply chain have many limitations; an analytics-based method might avoid some of them
 
Medicare Star ratings: the billion-dollar opportunity for providers
New incentives for health plans could alter the way payers review new drugs
Ensuring the quality of comparative effectiveness research
As payers seek higher-quality data from real-world treatment settings, the importance of reliable measures becomes critical
 
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