Archive for the ‘Law’ Category

Posted by dreamer On December - 12 - 2012 0 Comment

President Obama signed the FDA Safety and Innovation Act (FDASIA).  This law includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as other medical device provisions.  MDUFA III will be in effect for five years beginning October 1, 2012.  It includes performance goals and user fees paid to the Food and Drug Administration (FDA) by medical device companies when they register and list with the FDA and when they submit an  [ Read More ]

Posted by dreamer On December - 5 - 2012 0 Comment

The FDA Safety and Innovation Act (FDSIA) gives FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development.  This is the fifth reauthorization of the Prescription Drug User Fee Act or PDUFA, first enacted in 1992, and the third reauthorization of the Medical Device User Fee Act, or MDUFA, first enacted in 2002.  [ Read More ]