Regulatory

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.
Dec 12, 2016
Pharmaceutical Executive
Republican control of Washington promises overhaul of healthcare and medical product regulation.
Dec 08, 2016
Uncertainty surrounds the future of drug pricing reform, causing industry observers to take a closer look at the policy views of the president-elect, state and Congressional lawmakers, and the general public.
Dec 05, 2016
Congress took a major step last month towards shoring up FDA operations and biomedical research supported by the National Institutes of Health with House passage of the 21st Century Cures bill.
Nov 29, 2016
The European Medicine Association is determined keep open all options on the future of drug approvals in advance of a crucial meeting in December, writes Reflector.
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