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FDA braces for user fee reauthorization delay even as DMF submissions rise in H1 2022

Though the year 2021 was eclipsed by the Covid-19 pandemic, there was no let up in the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting drug master files (DMFs) to the US Food and Drug Administration (FDA). That trend has only gathered momentum this year.

The pace of submissions of type II DMFs to the FDA has been slightly higher in the first half (H1) of 2022 as compared to the first halves of the last three years. A total of 350 type II DMFs were submitted in H1 of this year, as opposed to 329 witnessed in H1 of 2021 and 293 submissions in H1 of 2020. In H1 of 2019, there were 321 type II DMF submissions.

DMFs are submissions made to the FDA by manufacturers who provide the agency with confidential, detailed information about facilities, processes or articles used in manufacturing, processing, packaging and storing of human drug products.

Overall, 2022 has so far seen a 10.8 percent rise in DMF submissions. A total of 493 DMFs (type II, III, IV and V) were submitted in the first half of this year. In comparison, the agency had received 445 DMF submissions in H1 of 2021, 432 in H1 of 2020 and 446 in H1 of 2019. The total DMF submissions were 913 during 2021, 931 in 2020 and 894 in 2019...[PharmaCompass]



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