Regulatory

Apr 05, 2017
Amidst hundreds of presentations on new developments in cancer research and treatment discovery at the AACR meeting this week, FDA policies for speeding promising new therapies to patients garnered a good deal of attention.
Apr 04, 2017
Even though uncertainty still exists with Trump’s presidency, current laws will remain intact for the time being. That’s why having a strong compliance strategy in place is the safest bet for all life sciences companies. This article reviews the top of compliance for pharma to be on the look out for.
Mar 28, 2017
By Pharmaceutical Executive Editors
The development of highly effective cures for hepatitis C has prompted a panel of experts to propose an innovative financing arrangement to make these therapies more available to “neglected” populations in the U.S.
Mar 28, 2017
Jill Wechsler outlines how the new FDA commissioner tasked with curbing regulation, speeding approvals—and collecting more fees to do it.
Mar 22, 2017
FDA efforts to speed more new generic drugs to market probably won’t do much to reduce high drug prices, writes Jill Wechsler.
Mar 16, 2017
NICE and NHSE have been grappling with the issue of affordability. Leela Barham reports.
Mar 14, 2017
Thomas Christensen outlines some of his lessons learned for first time OPDP submissions, promotional material, and labelling.
Mar 14, 2017
Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.
Mar 07, 2017
An FDA Memo addressing First Amendment legal issues regarding off-label use of medical products falls short of the necessary clarity, write Jamie Kendall and Alexandra Schulz.
Mar 06, 2017
Pharmaceutical Executive
Attack on treaties and imports threatens international operations.
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