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# Suggestions for FDA Draft Guidance on Some Oncology Studies
- URL: https://www.fdaweb.com/suggestions-for-fda-draft-guidance-on-some-oncology-studies/
- Published: 2026-08-04T12:00:00.000Z
- Updated: 2026-09-14T13:44:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161577

Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for publishing a draft guidance on streamlining nonclinical safety studies for some oncology pharmaceuticals, particularly biologics and conjugated products. The association’s comment [letter](https://www.regulations.gov/comment/FDA-2026-D-2839-0071?ref=fdaweb.com) says issuance of the draft is a significant step toward implementing FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. PhRMA says that while it strongly supports the draft guidance, maximizing its impact will depend on **(1)** preserving the flexibility inherent in existing FDA and International Council for Harmonization guidances; **(2)** providing sufficient regulatory predictability for sponsors making early development decisions; and **(3)** ensuring consistent implementation across review divisions. PhRMA submits recommendations it says will support the three objectives.

The American Association for Cancer Research (AACR) [says](https://www.regulations.gov/comment/FDA-2026-D-2839-0073?ref=fdaweb.com) it strongly supports FDA’s efforts to modernize nonclinical safety assessment and makes recommendations in these areas it says will further strengthen the draft:

- expand the discussion of weight-of-evidence assessments;
- expand product-specific recommendations; and
- clarify that the weight-of-evidence assessments are iterative.

“AACR applauds FDA’s continued leadership in advancing modern, science-based approaches to oncology drug development and believes this draft guidance represents an important step toward more efficient, evidence-based nonclinical safety assessment for oncology therapeutics,” the letter concludes.

The Critical Path Institute [encourages](https://www.regulations.gov/comment/FDA-2026-D-2839-0069?ref=fdaweb.com) FDA to continue fostering flexibility in the application of the guidance across therapeutic areas and product types while recognizing the importance of context-specific scientific justification.

Finally, the American Association of Pharmaceutical Scientists [provides](https://www.regulations.gov/comment/FDA-2026-D-2839-0059?ref=fdaweb.com) specific line-by-line comments.