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The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
Medicare Part D beneficiaries could shop for drugs at more pharmacies and take advantage of cheaper new generics sooner under revised rules proposed by the Centers for Medicare and Medicaid Services. Read More
The FDA unveiled its new regenerative medicine oversight framework — the regulation of promising stem cell treatments, engineered tissues and cell therapies — by publishing four guidance documents focused on speeding development and clarifying the agency’s enforcement actions over the next three years. Read More
A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid (thalidomide) and Revlimid (lenalidomide). Read More
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Read More
A federal judge declined to block Maryland’s new law on generic drug price-gouging that went into effect Oct. 1, but said a challenge based on the law’s vagueness can proceed. Read More