FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER Shifts Dispute Resolution Program Due to Spike in Generic Appeals

June 13, 2018
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An increased number of generic appeals has led CDER to transfer the management of its Formal Dispute Resolution program for sponsors of user fee products from the Office of New Drugs to the Office of Executive Programs, CDER Director Janet Woodcock said in a staff memo.

The program was previously managed by the OND because that office received a large number of appeals annually. But the Office of Generic Drugs has received an increasing number of appeals in the past four years, and in 2017 the number of appeals reviewed by the OGD exceeded the number in OND for the first time, Woodcock said.

The transition of the program to OEP “allows center-level management of the FDR program,” but OND and OGD will continue to manage appeals that reside at their respective office or super-office levels, she said.

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