The 46-page document, which outlines how the agency will use the user fees provided to it from industry, breaks down not only the planned deadlines for new guidance documents and pilot projects, but also highlights recurring themes of recent importance, including on patient input to the regulatory process, use of real-world evidence, biomarker qualification and increased pharmacovigilance.
The new review times for new drug applications (NDA) and biologics license applications (BLA), as well as goals on original efficacy supplements, resubmitted efficacy supplements, original manufacturing supplements and review performance goal extensions, are summarized in the following chart:
Table 1: Original and Resubmitted Applications and Supplements:
SUBMISSION COHORT STANDARD PRIORITY NME NDAs and original BLAs 90% in 10 months of the 60 day filing date 90% in 6 months of the 60 day filing date Non NME NDAs 90% in 10 months of the receipt day 90% in 6 months of the receipt day Class 1 Resubmissions 90% in 2 months of the receipt day 90% in 2 months of the receipt day Class 2 Resubmissions 90% in 6 months of the receipt day 90% in 6 months of the receipt day Original Efficacy supplements 90% in 10 months of the receipt day 90% in 6 months of the receipt day Class 1 Resubmitted Efficacy Supplements 90% in 2 months of the receipt day 90% in 2 months of the receipt day Class 2 Resubmitted Efficacy Supplements 90% in 6 months of the receipt day 90% in 6 months of the receipt day
Table 2:
PRIOR APPROVAL ALL OTHER Manufacturing Supplements 90% in 4 months of the receipt day 90% in 6 months of the receipt day
In addition, the document offers details on FDA’s program for better review transparency and communications between FDA and industry, as well as information on clinical holds, the major dispute resolution process, information on special protocol question assessment and agreements and goals for the review of proprietary names to reduce medication errors.
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