Regulatory

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.
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.
Jan 17, 2017
The long-cherished dream of finding a European approach to assessing the value of new medicines seems to recede further with every step taken to pursue it, writes Reflector.
Jan 17, 2017
Health reform, pricing pressures will shape drug marketing and development in 2017, writes Jill Wechsler.
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