ANDA Review: Moving From Tentative To Final Approval Could Require 10 Months Or More
US FDA draft guidance says substantive changes to reference product may require major ANDA amendment and 10-month review goal for the generic.
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More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.
Federal courts and USPTO will soon run out of funds that have allowed them to continue normal operations; pending ANDAs to get same filing date, which could lead to FDA legal challenges.
ANDA and NDA/BLA supplement approvals continue thanks to carryover user fee funds, but US FDA hasn't made any NDA and BLA approvals during shutdown as as anxiety over effect of "lapse period" on agency increases.