Regulatory

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
By
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.
Feb 21, 2017
The risk of non-compliance with export controls, and the associated civil and criminal penalties, are very real given the sensitive and global nature of the biopharmaceutical industry’s work. This article outlines steps companies should take to ensure compliance with export controls.
Feb 10, 2017
In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation an efficient, rigorous FDA regulatory system, writes Jill Wechsler.
Feb 06, 2017
Pharmaceutical Executive
Congress is poised to tackle exorbitant drug prices through health reform and FDA legislation.
Feb 02, 2017
This article provides an overview of the Procedural Guidance from the FDA “Medical Product Communications That are Consistent with the FDA Required Labeling,”released early this year. In addition to providing a list of three factors manufacturers should use to determine if product communications are consistent with the FDA-required labeling, FDA clarifies what is meant by information consistent with the FDA-required labeling.
Feb 01, 2017
Pharm Exec speaks to ICON's Ramita Tandon about how the UK and European regulators' market access plans for 2017 will affect the industry.
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