On Friday, 18th August 2017, the US President signed into law the Food and Drug Administration Reauthorization Act (FDARA).
FDARA includes a reauthorization of four of the medical product user fee programs, the Prescription Drug User Fee Amendments, Medical Device User Fee Amendments, Generic Drug User Fee Amendments, and Biosimilar User Fee Amendments.
FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time, which allows FDA to continue to collect medical product user fees through fiscal year 2022.
For more information please refer to the blog of FDA: FDARA: Making a Difference for Industry and Patients
Asphalion will perform a free webinar next September 20th 2017 at 15:00h (CEST) with our US Agent, Mr Bruce Thompson from Reguliance, with 25 years of experience in the US Agency, as well as Asphalion’s own FDA expert team.
If you are interested in FDA Regulatory Affairs this will be a great opportunity to get to know the latest news and to obtain a solid introduction into US drug regulations.
