Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the ANDA Submissions topic
No spam. Unsubscribe anytime.
Presenter Lynn reiterates August 1 progress-update expectations for ANDAs and interim releases
Summary
Lynn told manufacturers that confirmatory testing and mitigation submissions were expected by Aug. 1, and that firms unable to meet that date must file a detailed progress update with scientific justification and batch data for products released under interim limits.
Lynn said FDA had expected confirmatory testing and mitigation submissions by Aug. 1 but recognized some mitigation changes take longer; firms that cannot finish confirmatory testing and mitigations by that date must submit a progress update on the same due date and include scientific justification for incomplete items.
She specified that when products are released against interim limits (Table 3) to avoid shortages, the progress update must also include batch release and batch stability data for those batches released under the interim limit so FDA can base any duration-period updates on empirical evidence. Lynn warned that a partial update without scientific explanation will be insufficient and recommended firms contact the drug-shortage staff with questions.
