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FDA issues draft guidance on early-phase IND protocols for solid tumours

🇺🇸 FDA CBER · Tue 10 Nov 2026

The Oncology Center of Excellence draft covers first-in-human trials and products with limited human experience; comments are open until 11 January 2027.

The US Food and Drug Administration has published a draft guidance with recommendations for sponsors and clinical investigators who design early-phase oncology trials in solid tumours. The document is dated 10 November 2026 and was issued by the agency's Oncology Center of Excellence.

It applies to early-phase protocols submitted under an Investigational New Drug (IND) application. These include first-in-human protocols and protocols for drugs and biological products with limited human experience. Submissions go to the relevant disease-specific division in the Center for Drug Evaluation and Research's Office of Oncologic Diseases, or to the Center for Biologics Evaluation and Research's Office of Clinical Evaluation.

The scope is limited to solid tumours. The guidance states that it does not address protocols for investigational drugs intended to treat haematological malignancies.

Comments can be submitted online or by post to the FDA Dockets Management office in Rockville, Maryland, under docket number FDA-2026-D-13432. To be considered before work begins on the final version, comments should arrive by 11 January 2027. The agency notes that comments on any guidance can be filed at any time.

As a draft, the text is not final. In general, FDA draft guidances set out the agency's current thinking and are open to revision after public comment.

What it means for your team

  • Sponsors planning first-in-human or limited-experience solid-tumour INDs should read the draft against their current protocol design approach.
  • Teams should check which review office, CDER/OOD or CBER/OCE, will handle their product, since the guidance covers both.
  • Sponsors developing haematological malignancy products should note that this draft excludes them.
  • Comments to docket FDA-2026-D-13432 by 11 January 2027 give the best chance of influencing the final version.

Official source: FDA CBER ↗

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

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