Tag Archives: Regulatory
By Guest Blogger | Published: May 21, 2013
by Tom Norton If you are an Rx regional sales director or a product marketing manager, I have a somewhat provocative question for you: How exactly are you planning your 2014 Medicaid strategy?
By Ben Comer | Published: May 7, 2013
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]
By Guest Blogger | Published: April 17, 2013
By Jill Wechsler, Washington Correspondent. The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to help [...]
By Guest Blogger | Published: February 25, 2013
By Jacob Presson, Research Analyst at Cutting Edge Information. Regulations concerning the contents of patient package inserts (known in the EU as “patient information leaflets” or PILs) have in the past erred on the side of caution, making sure that all of the necessary information about side effects and cross-prescription conflicts was included. Pharmaceutical companies have [...]
By Ben Comer | Published: December 5, 2012
If a drug’s label is not the final word on what is true – or untrue – about a product, then who decides what can and cannot be said during a sales detail?