Regulatory

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.
Dec 21, 2016
2016 has been the year of the unpredictable — and the uncertainties this has generated will multiply and dominate the agenda in Europe in 2017, writes Reflector.
Dec 13, 2016
Congress's enactment of 21st Century Cures legislation may have given pharmaceutical manufacturers an early Christmas present, but some concerns are being voiced, writes Jill Wechsler.
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