Clinical trialsGuideline · draft

FDA Issues Draft Guidance on Early-Phase IND Protocols for Solid Tumour Trials

🇺🇸 FDA · Thu 12 Nov 2026

The agency's draft guidance sets out recommendations for first-in-human and limited-experience oncology protocols, and excludes haematologic malignancies; comments are open until 11 January 2027.

The US Food and Drug Administration has announced the availability of a draft guidance for industry titled "Early-Phase IND Protocol Recommendations for Solid Tumors". The notice was published on 12 November 2026.

The document is aimed at sponsors and clinical investigators developing early-phase trials. These include first-in-human protocols, as well as protocols for drugs and biologic products that have limited human experience. All fall under an Investigational New Drug Application (IND).

Such protocols are submitted to the relevant disease-specific division within the Office of Oncologic Diseases in the Center for Drug Evaluation and Research (CDER). For biologics, they go to the Office of Clinical Evaluation in the Center for Biologics Evaluation and Research (CBER).

The scope is limited to solid tumours. The draft does not address protocols for investigational drugs intended to treat haematologic malignancies.

The notice states that the comment period ends in 61 days, on 11 January 2027. Comments can be submitted through Regulations.gov. As general context, draft guidance documents are non-binding and show the agency's current thinking while they remain open for public input.

What it means for your team

  • Oncology sponsors planning first-in-human or limited-experience solid tumour INDs should review the draft against their current protocol templates.
  • Teams working on haematologic malignancies should note that this draft does not cover their programmes.
  • Regulatory affairs groups have until 11 January 2027 to submit comments through Regulations.gov if they want to influence the final text.

Official guideline text: FDA ↗

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

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