The Food and Drug Administration Safety and Innovation Act, which Congress sent to President Obama on June 26, reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) with increased funding through fiscal year 2017. The Act also establishes new user fee programs for generic drugs and biologics and enacts several important reforms that will greatly impact FDA’s pre- and post-market regulation of the Life Sciences industry, including enhancements to accelerated drug approval programs, revisions to timelines for FDA responses to petitions, new transparency requirements in medical device reviews and several new authorities to streamline FDA’s regulatory processes.
Presented on July 17th for medical device professionals, and on July 19 for prescription drug, generic and biosimilar professionals, these two webcasts will feature Healthcare Practice attorneys, John Manthei, Daniel Meron and Rebecca Brandt.
For further information, please contact Michele Bravo.