Tag Archives: Regulatory
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?
By Guest Blogger | Published: November 7, 2012
by Tom Norton With the Presidential election decided and President Obama the clear winner, it’s time for Pharma to get down to business on the implementation of ObamaCare. Here are some of the key actions to anticipate between now and January 1, 2013.
By Guest Blogger | Published: September 25, 2012
Budget policies jeopardize FDA funding, user fees Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA), efforts to cut the federal deficit raises questions about how those fees will be collected and used in the coming year. FDA, [...]