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Monthly Archives: February 2012
FDA: Steps Toward Quantitative Safety Assessment
A new collaboration will move FDA closer to predicting adverse events – before they happen – as part of the regulatory process
In an article published in Nature last June, FDA’s Darrell Abernethy, Lawrence Lesko and Janet Woodcock outlined the agency’s desire to incorporate “mechanism-based drug safety assessment and prediction” into the regulatory approval process. [...]
Posted in FDA, R&D, Regulatory, Safety, Technology 1 Comment
A Dialogue on Patient Access Programs
As health reforms sweep in major changes to our nation’s healthcare system, patient assistance and access programs (PAPs) are rapidly evolving to assess and meet new needs. As millions of uninsured Americans gain some form of insurance coverage, manufacturer-sponsored PAPs face unprecedented challenges as they rise up to evolve the PAP model to best address [...]
Compliance: Europe Feels the Sunshine
As the perceived urgency for transparency and compliance in global pharma grows ever stronger, the ‘Sunshine provisions’ of the US’s Patient Protection and Affordable Care Act (ACA) seem increasingly aptly named. The spotlight that has been exposing and illuminating – and sometimes burning – issues around the financial interests of physicians and academic medical centers [...]
2012: A Good, Bad, and Ugly Year for France's Servier