GDUFA III

15
Nov

OGD Extolls Review Enhancement at GRx+Biosims Meeting

At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes.  He outlined a number of these changes from GDUFA II […]

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17
Oct

With GDUFA III Comes Revision to Many Guidance Documents – No Exception for PAS

With the coming of GDUFA III, many guidance documents have been changed, and new guidances have been released to address new issues under GDUFA III.  We have published posts describing many of the changes and now the FDA has issued an updated guidance on prior approval supplements (PAS) (here). The above‑cited guidance replaces the October 2017 guidance of […]

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07
Oct

GDUFA III User Fees, Guidances, and MAPPs Published October 5, 2022

There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA.  Rather than trying to paraphrase each Guidance and explain what changes have been made in the past […]

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04
Oct

Facility Not Ready for Inspection Used to Get a Pass but Not Anymore!

As former OGD Director Kathleen “Cook” Uhl, MD used to say, “Read the commitment letter.”  This certainly applies for GDUFA III and in spades.  Why?  Because a number of enhancements that were made in the GDUFA III negotiations are designed to make the review process more efficient and improve the number of first‑cycle approvals. In GDFUA I and […]

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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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