The US Food and Drug Administration (FDA) is delaying by two weeks the implementation of its facility registration requirements under the Generic Drug User Fee Act (GDUFA) , a subset of a recently passed FDA Safety and Innovation Act (FDASIA) . One of the law's main goals was to achieve parity between the way FDA collects fees from branded and generic pharmaceutical products. Under a long-standing program, FDA assesses user fees from branded pharmaceutical companies ...

The end is near-for marketing professionals waiting for the US Food and Drug Administration (FDA) to issue its long-discussed and long-delayed guidance on the appropriate use of social media for marketing healthcare products, that is. Buried deep within the FDA Safety and Innovation Act (FDASIA), signed into law on 9 July 2012 by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014. "Not later than 2 years aft...

The first hearing in the US Senate for the Prescription Drug User Fee Act ( PDUFA ) reauthorization has been scheduled for next week. The Senate Committee on Health, Education, Labor and Pensions' (HELP Committee) will meet on 29 March 2012 at 10:00 AM EST to discuss the act, which is requires renewal by the end of the year. Witnesses for the hearing have not yet been announced. The user fee legislation is on a fairly tight deadline, as Regulatory Focus reported...