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# Comments on Renal Function Study Draft Guidance
- URL: https://www.fdaweb.com/comments-on-renal-function-study-draft-guidance/
- Published: 2020-12-09T12:00:00.000Z
- Updated: 2026-09-14T16:39:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148267

Pfizer [says](https://www.regulations.gov/document?D=FDA-2010-D-0133-0038&ref=fdaweb.com) it is pleased with revisions FDA made to a 2010 guidance to eliminate unnecessary testing as shown in a draft guidance on pharmacokinetics in patients with impaired renal function for study design, data analysis, and impact on dosing.

A Novartis comment [letter](https://www.regulations.gov/document?D=FDA-2010-D-0133-0039&ref=fdaweb.com) says the scope of the draft guidance does not make it clear that it should not apply to gene therapies and cell therapies. “However, these modalities should be excluded from the requirement to perform renal impairment studies,” the company writes.

AbbVie [recommends](https://www.regulations.gov/document?D=FDA-2010-D-0133-0037&ref=fdaweb.com) that FDA include a statement that addresses whether a renal impairment study is advised for antibody drug conjugates if certain payload conditions are present.

All three companies also submitted line-by-line technical comments, as did [Merck](https://www.regulations.gov/document?D=FDA-2010-D-0133-0042&ref=fdaweb.com).