Regulatory

Aug 07, 2017
Jill Wechsler on the Senate's 94-1 vote to approve legislation reauthorizing user fees and a series of program changes to maintain a smoothly functioning FDA product review and approval process.
Aug 07, 2017
Pharmaceutical Executive
A review of the top contenders to land the agency as decision on its relocation draws closer.
Aug 04, 2017
Pharmaceutical Executive
The growing toll requires new assessment of risks, expanded provider education, and more scrutiny of marketed products.
Aug 03, 2017
Pharmaceutical Executive
The agency’s new commissioner unveiled new digital health pilot programs to help navigate regulatory requirements.
Jul 31, 2017
Internal oversight and the tools to remain compliant are critical to companies seeking to avoid corporate integrity agreements or efficiently fulfill existing agreements, writes Gabriela P. Baron.
Jul 24, 2017
Pharmaceutical Executive
Excitement over more new treatments for cancer and rare diseases is offset by cringing over prices.
Jul 21, 2017
The UK's proposed Accelerated Access Review is being dogged by delay and disappointment, writes Leela Barham.
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.
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