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# Technical Comments on Food Effects Draft Guidance
- URL: https://www.fdaweb.com/technical-comments-on-food-effects-draft-guidance/
- Published: 2019-05-02T12:00:00.000Z
- Updated: 2026-09-15T01:24:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144006

Janssen says that an FDA draft guidance on assessing food effects on drugs would be enhanced if the use of physiologically-based pharmacokinetic modeling were permitted and incorporated into the guidance. The company’s comment [letter](https://www.regulations.gov/document?D=FDA-2018-D-4368-0009&ref=fdaweb.com) also includes line-by-line specific comments. Specific technical comments also were submitted by [Pharmaceutical Education and Research with Regulatory Links](https://www.regulations.gov/document?D=FDA-2018-D-4368-0011&ref=fdaweb.com), [Roche/Genentech](https://www.regulations.gov/document?D=FDA-2018-D-4368-0002&ref=fdaweb.com), [Novartis](https://www.regulations.gov/document?D=FDA-2018-D-4368-0010&ref=fdaweb.com), and [AstraZeneca](https://www.regulations.gov/document?D=FDA-2018-D-4368-0007&ref=fdaweb.com).