RegulatoryOfficial

FDA office lists four 2026 guidance priorities and 11 topics for 2027-2028

🇺🇸 FDA CBER · Fri 06 Nov 2026

The Office of Health Advancement guidance agenda covers combination products, emergency use authorisation, informed consent, paediatric research and orphan designation, with public comment invited.

FDA has published guidance agendas from its Office of Health Advancement (OHA) for public review and input. The page refers to both OHA and OCMO, and uses OCMO when describing the lists. One list covers guidance documents the office intends to publish in calendar year 2026. The other covers documents it plans to develop for 2027-2028 as resources permit.

The four 2026 priorities are: essential drug delivery outputs for devices intended to deliver drugs and biological products; current good manufacturing practice requirements for combination products; labelling for infusion pumps that deliver subcutaneous insulin; and emergency use authorisation of medical products and related authorities. The first three are led by the Office of Combination Products. The fourth is led by the Office of Public Health Preparedness and Response.

The 2027-2028 list has 11 topics. Three come from the Office of Clinical Policy: key information and facilitating understanding in informed consent, payment and reimbursement to research participants, and IRB waiver or alteration of informed consent for minimal-risk research under 21 CFR 50.22. FDA notes that the first and third are being developed with the HHS Office for Human Research Protections.

The Office of Combination Products leads four more: unique device identifier requirements for combination products, submissions for postapproval modifications, technical considerations for demonstrating the reliability of emergency-use injectors, and where to submit cross-center master files. The Office of Pediatric Therapeutics has two topics on ethical considerations and referral processes for research involving children. The Office of Orphan Products Development has two on orphan drug designation requests and a programme overview.

FDA says the lists include topics with no existing guidance, topics where updates may help, and topics with draft guidances that may be revised or finalised after comments. It states that it is not bound by the lists, need not issue every document on them, and may issue guidance on other topics. Comments go to docket FDA-2024-N-5427 on regulations.gov and can be submitted at any time. FDA asked for comments by 8 June 2026, a date that precedes this page's 4 November 2026 currency date.

What it means for your team

  • Combination product and device-drug teams should note that GMP, drug delivery outputs, UDI and postapproval modification topics all feature on the agenda.
  • Clinical operations and regulatory teams can track planned informed consent, participant payment and IRB waiver guidance, the last of which is being developed with the HHS Office for Human Research Protections.
  • Sponsors of orphan and paediatric programmes should watch for orphan designation request formatting and paediatric ethics guidance.
  • The lists are non-binding and the page gives no publication dates, so they should be used as planning signals only.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

More Regulatory All →