An article on Genetic Engineering & Biotechnology News discusses President Barack Obama’s recent decision to sign the FDA Safety and Innovation Act into law.
“The FDA Safety and Innovation Act (S.3187) includes PDUFA V among a set of user-fee measures that for the first time will include collection of fees for biologic and generic drugs. PDUFA V is projected to fund 2,599 full-time equivalent (FTE) staffers, whose duties will include helping FDA carry out its commitment under the law to review and act on 90% of standard applications within 10–12 months from the date of filing and on 90% of priority submissions within six to eight months from date of filing. In return, the start of the agency’s first review cycle clock was pushed back to after its 60-day administrative filing review period.”
To read the entire article, click here.