Legal & Regulatory

Oncology drug development pipelines are overflowing, but the sky-high prices of these agents are turning reimbursement schemes, and the very practice of cancer medicine, on their heads

CDC is depending on a new distribution process for ‘the largest vaccine distribution in history’

In whatever form biosimilar legislation might take, patent holders will need to review their patent portfolios carefully

States pile on rules; industry wishes for consistency

While storm clouds gather over pharma sales activities, marketers look to e-sampling as a potential alternative

Drug sponsors have options in both how the new FDA risk programs are structured and how to execute them

While FDA guidance on appropriate medical communication has evolved, US Dept. of Justice attention the practice is intensifying

Expect a flood of product-liability suits in the aftermath of Wyeth vs. Levine

Regulatory attention has intensified over commercial activities. Here’s what to do to minimize risks and raise compliance levels

Multiplying state laws on marketing and distribution disclosures might be pre-empted by new federal legislation

FDA specifies a patient registry and follow-up studies