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# Comments on FDA ‘Medical Queries’
- URL: https://www.fdaweb.com/comments-on-fda-medical-queries/
- Published: 2022-11-01T12:00:00.000Z
- Updated: 2026-09-14T18:04:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153096

Eli Lilly says it appreciates FDA’s efforts to better standardize safety data and analysis. Commenting on an agency docket on Advancing Premarket Safety Analytics, Lilly [asks](https://www.regulations.gov/comment/FDA-2022-N-1961-0028?ref=fdaweb.com) that the agency “support efforts in ensuring the document describes a customized approach, which may bring the necessity for updating some terms with each update to MedDRA (Medical Dictionary for Regulatory Activities). “Additionally,” it says, “some preferred terms are not present in MedDRA, which may unintentionally result in coding issues by the investigators or healthcare professionals.”

The letter has specific comments for these safety topics: hypersensitivity, anaphylaxis, angioedema, malignancy, depression, self-harm, psychosis, anxiety, pancreatitis, volume depletion, decreased appetite, constipation, diarrhea, dyspepsia, hepatic failure, hepatic injury, hypotension, nausea, vomiting, and study agent abuse potential.

In its [response](https://www.regulations.gov/comment/FDA-2022-N-1961-0031?ref=fdaweb.com), AbbVie provides both general and specific comments on two documents prepared by FDA for a 9/14/22 public workshop on Advancing Premarket Safety Analytics Workshop.