FDA FY 2021 Postmarketing Report Shows Sponsor Compliance Lagging
Sponsors still are falling behind in their postmarket reporting, according to the FDA’s yearly update on progress of postmarketing requirements/commitments.
Counting both new drug applications (NDA) and biologics license applications (BLA), only 79 percent of the 752 annual postmarket reports that were due to the FDA in 2021 met their deadlines; 13 percent were late and 9 percent went unsubmitted.
These figures are very close to fiscal year 2020 stats, which show 24 percent of total annual status reports were either late or completely unfiled by sponsors.
Of the 566 expected NDA annual status reports in fiscal 2021, 79 percent came in on time, 12 percent were late and 10 percent were not submitted by sponsors at all.
For the 186 BLA status reports the agency anticipated last fiscal year, 78 percent were on time, 15 percent came in late and 7 percent were not filed.
Read the full report here: https://bit.ly/3HRNJsD.
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