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 06, 2017
From Applied Clinical Trials
The temptation to use uncontrolled, early, small studies to support further development of products may prove problematic for emerging biopharma companies.
Feb 03, 2017
Pharmaceutical Executive
There are question marks when trying to size up the trajectory of the global pharma industry in 2017. One certainty, however, will be change.
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.
Jan 24, 2017
From Applied Clinical Trials
The Expert Determination standard of protecting patient privacy can answer the growing demand for better data for research and analytics in healthcare.
Jan 04, 2017
Connected ecosystems will change the future of healthcare. William King outlines three key value drivers.
Dec 12, 2016
Pharmaceutical Executive
How a Manufacturing Excellence program can deliver competitive advantage to a fast-changing global product mix—at lower cost, and with an unexpected workforce dividend to boot.
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 08, 2016
It's time to take advantage of a nascent technology embrace taking hold among market insights professionals, writes Janet Kolsoff.
Nov 30, 2016
How the need for biopharma innovation extends to questions around executive compensation. By Carl Sjostrom and Ian Wilcox
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