Legal and Regulatory

Industry and regulators are taking steps to revolutionize the basic regulatory function of collecting and analyzing adverse medical events

More pieces for industry-wide track-and-trace are falling into place, but there’s no rush to authenticate products

Senator Michael Bennet wants better FDA oversight of drug supply chain and material sourcing, as survey shows that 36% of Americans likely to vote have heard of unsafe ingredients

A Process-Based Assessment (PBA) is the first step to analyzing reporting needs

REMS programs need to address stakeholder usability

To avoid anti-kickback litigation with government, pharma companies need a defensible position on FMV assessments

The growing number of states with laws now are joined by the “51st state”: the federal government

Growing digitization of patient data could break the threshold to better adherence to medication therapies

Kaiser Permanente files a citizen’s petition to revise FDA’s process of imposing REMS programs, also objects to restrictions on wholesale-distribution

Sharps Compliance Corp. lauds California law to raise the profile of proper consumer disposal of used sharps. Next up: unused pharmaceutical returns

FDA sets a precedent for granting generic approvals even when initial litigation goes against the generic manufacturer

Nearly 30% of acquiring companies do not evaluate FCPA risks prior to an acquisition

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