GDUFA and BsUFA User Fees – Time to pay the piper!

FDA’s User Fee Staff provided an overview of the progress and implementation of the first year of GDUFA II and BsUFA II user fees during the afternoon session of the second day of the GRx +Biosims Conference held at Baltimore, MD from September 5-7. The presentation recapped how the user fee structure for GDUFA II an BsUFA II changed,

Expedited Review, Priority Review, CTG – What’s the difference?

On the second day of the first annual 2018 GRx+Biosims Meeting in Baltimore, MD held from September 5-7, 2018, Kurt Karst, JD and Mark Schwartz, JD (Directors, Hyman, Phelps & McNamara, P.C) provided a very informative overview of cGMP trends and emerging legal issues concerning GDUFA and FDARA. The on-going modernization of the generic drug approval process has presented industry with new legal considerations.

Simplifying the Complex Generics

During the afternoon session at the first annual GRx+Biosims Meeting held in Baltimore, MD, from September 5-7, 2018, a panel discussion was held to deliberate over aspects that are important to consider when developing a complex generic drug product. The panel consisted of FDA as well as generic industry representatives. GDUFA II provides drug manufacturers with several tools to assist in the development of complex generic drug products including enhanced communication opportunities with FDA and opportunities for innovative approaches in developing a complex generic drug.

BsUFA and GDUFA – Time to Pay

The Food and Drug Administration announced yesterday that the Biosimilar User Fee (BsUFA) program invoices for Fiscal Year (FY) 2019 were emailed to sponsors on August 27, 2018.  Sponsors should expect to receive their invoices by August 29, 2018.  This follows the PDUFA FY 2019 PDUFA program fee invoices which were emailed on August 15,