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Risk Evaluation & Mitigation Strategy (REMS) programs are evolving, with new complexities for compliance managers

The dynamic evolution of multi-sponsor REMS

Using real-world databases for evidence development has strengths and weaknesses; with electronic health records (EHRs), new approaches are evolving

The value of real-world data in drug commercialization

Group passes the initial ICANN evaluation; will NABP be the international policeman of online pharmacies?

NABP is on its way to owning the .Pharmacy domain suffix (gTLD)

PDMA Alliance: Change is the new norm

More compounding pharmacy recalls worsen the situation; FDA looks for new legislation

Drug shortages continue to challenge health systems

Academic study finds evidence of an early warning system in anonymized Web searches

Will crowd-sourced online search data become a better 'sentinel' for adverse event reporting?

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

Lessons learned on bona fide service fees and fair market value-is there a 'right answer'?

Number of cases opened by FDA's Office of Criminal Investigations (OCI) triples to 170

Criminal investigations for counterfeit, diverted drugs skyrocketed in 2012

As the business grows at double-digit rates, representing its interests becomes its own business opportunity

Who will represent the specialty pharmacy business?

A new policy debate over drug regulation is emerging as the NECC scandal worsens

Legal and Regulatory