07
Sep

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 […]

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06
Sep

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 […]

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28
Aug

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, […]

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