Tag Archives: Regulatory
By Guest Blogger | Published: September 24, 2014
What can be gleaned about the direction that health policy will take for the next five years under the new European Commission, scheduled to take office at the beginning of November? Peter O’ Donnell address this question in his new Applied Clinical Trials column here.
By Julian Upton | Published: June 12, 2014
They say the road to hell is paved with good intentions. The row in the UK over NICE’s call to doctors to increase the use of statins looked to be good example of this handy aphorism. That was until things took a potentially darker turn.
By Jill Wechsler | Published: June 6, 2014
The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference on June 5 in Washington, D.C., featuring key FDA officials and industry leaders. This collaborative effort to streamline and coordinate manufacturer audits of ingredient suppliers was launched in 2009 in response to the heparin adulteration crisis, which raised broad concerns […]
By Guest Blogger | Published: June 2, 2014
One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”. The European Directorate for the Quality of Medicines & Healthcare, which is responsible for the European Pharmacopoeia but also runs its own inspection operations, has been tightening […]
By Guest Blogger | Published: May 21, 2014
By Leela Barham. There has been a lot of concern about the decision to give the National Institute for Health and Care Excellence (NICE) the responsibility to look at “highly specialized technologies” (HSTs, or orphan drugs to you and me). That decision was taken just as the NHS across England was going through major reform […]