Unlock The True Value of Digital Communication: Knowledge, Motivation, Context
March 6th 2014Interaction between pharma representatives and doctors has traditionally been a paper-based and static experience in which the representative enters with one-quarter of a campaign in hand and then tries to deliver the remaining pieces three more times through the year.
Track-and-Trace Not Enough to Halt Drug Counterfeiters
March 4th 2014Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight.
New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman
February 25th 2014When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process for generic drugs, and combat the agency’s backlog of drug applications.
Ranbaxy Suspends Shipments, Addresses Quality and Integrity Problems
February 24th 2014Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.
Industry Takes EU to Task Over Pharmacovigilance Fees
February 21st 2014Europe’s main pharma industry bodies - EFPIA, EGA, EuropaBio, AESGP and EUCOPE - have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010?.
How Good for UK Pharma is the European Union?
February 13th 2014As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman.
EMA Clarifies Marketing Authorization Categories
February 12th 2014The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013.