Cover storyAgeing biology underlies nearly every chronic disease. This piece explores geroscience and why targeting ageing may be pharma's next big category.
FDA has licensed CYFENDUS for anthrax post-exposure prophylaxis using animal-only efficacy data, setting a regulatory benchmark for biodefense biologics.
FDA outlines mandatory eHCTERS registration, annual December updates, and 30-day amendment windows for HCT/P establishments under 21 CFR Part 1271.
CBER ceased notarizing export certificates in 2014; regulatory teams should confirm BECATS submission workflows and State Dept. apostille routes for destination markets.
CBER's active roles in ICH and APEC RHSC are reshaping how biologics manufacturers approach multi-market regulatory alignment.
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