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# 35 Items on CDER CY2026 Guidance Agenda
- URL: https://www.fdaweb.com/35-items-on-cder-cy2026-guidance-agenda/
- Published: 2026-01-13T12:00:00.000Z
- Updated: 2026-09-14T15:30:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160482

CBER has released its calendar year 2026 guidance [agenda](https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/guidance-agenda-guidance-documents-cber-planning-publish-during-calendar-year-2026?ref=fdaweb.com) showing it plans to produce 35 draft and final guidances in four categories — Blood and Blood Components (five guidances), Therapeutic Products (19 guidances), Other (two guidances), and Vaccines and Allergenics (nine guidances).

In the Vaccines and Allergenics category, CBER says it intends to produce draft guidances on the evaluation of combination vaccines for preventable disease, development of vaccines to prevent pneumococcal disease in adults, clinical data needed to support the licensure of seasonal inactivated influenza vaccines, clinical data needed to support the licensure of pediatric influenza vaccines, development and licensure of vaccines to prevent Covid-19, and development of vaccines in pregnant women.