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FDA to release new guidance on biosimilar labeling, generic opioids

PCMA SmartBrief | Mar 02, 2015

The FDA's Center for Drug Evaluation and Research has announced plans to release new guidance documents on biosimilar labeling and generic opioids this year. The biosimilar labeling guidance will address the issue of what "generic" name biosimilars will be given to differentiate them from the drugs they reference, while the opioid guidance will contain principles for evaluating abuse-deterrent properties of generic opioid drugs. Regulatory Focus (02/27)


Requiring payers to cover higher specialty drug costs will raise insurance premiums

PCMA SmartBrief | Mar 03, 2015

Telemarketing pushed compounded drugs with no proven benefit

PCMA SmartBrief | Feb 25, 2015

Healthcare Solutions to be acquired by Catamaran

PCMA SmartBrief | Feb 27, 2015

CMS factors expensive hepatitis C drugs into Part D risk models

PCMA SmartBrief | Feb 26, 2015

Sandoz puts off launch of biosimilar version of Neupogen

PCMA SmartBrief | Feb 26, 2015

Big Pharma refills portfolios with expensive drugs

PCMA SmartBrief | Feb 27, 2015

House committee approves bill to reduce Medicare drug fraud at pharmacies

PCMA SmartBrief | Feb 27, 2015

Lawmakers pass bill to postpone e-prescribing mandate in N.Y.

PCMA SmartBrief | Mar 02, 2015

Shrinking the Part D doughnut hole has saved seniors $15B, HHS says

PCMA SmartBrief | Feb 25, 2015


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