Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

HERE YA GO:

Hot off the press:

GDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES

FISCAL YEARS 2023-2027

The performance goals and procedures of FDA, as agreed to under the third authorization of the generic drug user fee program, are summarized below. Unless otherwise stated, goals apply to cohorts of each fiscal year. For the purposes of calculating all time periods in this Commitment Letter, FDA will calculate the goal date from the day after a submission, to be consistent with FDA’s other user fee programs.

I. SUBMISSION ASSESSMENT PERFORMANCE GOALS
A. Original ANDAs and Amendments
1. Assess and act on 90 percent of standard original ANDAs within 10 months of the
date of ANDA submission, subject to any adjustments to the goal dates described in
section I(A)(3).


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