Regulatory

Jul 21, 2017
Value frameworks are now "sexy". In the US, no fewer than five have emerged since 2015. Leela Barham discusses how the landscape is evolving.
Jul 18, 2017
The Association of the British Pharmaceutical Industry has sought permission for a Judicial Review of the National Institute for Health and Care Excellence’s unpopular changes to tackle drug affordability.
Jul 15, 2017
Mary Ann Slack and Mitra Rocca outline how FDA is adopting electronic practices and initiating efforts to simplify the submission process for new drug and generic drug applications.
Jul 14, 2017
With the US Institute for Clinical and Economic Review (ICER) looking like it is here to stay, Leela Barham reviews its value framework.
Jul 13, 2017
In the second of her articles on value assessment, Leela Barham discusses the emergence of multiple frameworks in the US and considers their impact.
Jul 06, 2017
The FDA ruling that exempts biosimilar makers from waiting an extra six months after approval to distribute a new product should help overcome delays in future biosimilar sales, writes Jill Wechsler.
Jun 19, 2017
Pharmaceutical Executive
Last month’s EFPIA and EU Health Council annual conferences highlighted the growing divisions—and resentments—between industry and governments on drug pricing. Reflector reports.
Jun 16, 2017
Congressional measures lack the support to move forward, writes Jill Wechsler.
Jun 09, 2017
Pharmaceutical Executive
A look at evidence and value in a time of social and policy change.
Jun 08, 2017
Pharmaceutical Executive
In the 21st Century Cures Act, Congress excluded from FDA regulation certain clinical decision support, or CDS, software.
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