05
Nov

A Look at the Reporting Requirements Described in the GDUFA III Commitment Letter

The FDA is changing its reporting requirements for GDUFA III.  It appears from the changes that some information may be more difficult to gather and will be removed from the monthly Generic Drugs Program Activities Report we have all come to love and will be moved to either quarterly or annual reports. The monthly report […]

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31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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16
Dec

OGD Finalizes Controlled Correspondence Guidance

While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I.  Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]

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04
Nov

Question: Which former acting deputy director of OGD just competed in Orange Book Jeopardy at AAMs Virtual GRx-Biosims Conference?

Answer: Who is Bob Pollock? Next week, November 9-11, the Association for Accessible Medicines (AAM) will be hosting a virtual version of the GRx+Biosims conference. As a part of it, an Orange Book Jeopardy was held between 3 Orange Book virtuosos: Kurt Karst of Hyman, Phelps & McNamara, David Rosen of Foley Lardner, and our […]

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