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# PhRMA Comments on Drug Labeling Guidance
- URL: https://www.fdaweb.com/phrma-comments-on-drug-labeling-guidance/
- Published: 2023-03-15T12:00:00.000Z
- Updated: 2026-09-14T18:19:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153985

Pharmaceutical Research and Manufacturers of America (PhRMA) says a revised FDA draft guidance on the content and format of the Dosage and Administration section of labeling for human prescription drug and biological products provides more detail and direction than its previous 2010 document. PhRMA [says](https://downloads.regulations.gov/FDA-2007-D-0201-0010/attachment%5F1.pdf?ref=fdaweb.com) the revised guidance “will provide useful information for consideration during labeling development for new products and new uses of existing products.”

The trade group says it encourages the agency to acknowledge in the final guidance that certain dosing-related information, including pediatric information, may be included, and even required, in other sections of the labeling.

The PhRMA letter also has specific comments on Organization and Format; Critical Information for the Safe and Effective Use of the Drug; Other Therapy Used Before, During, or After Drug Treatment or Administration; Additional Preparation and Administration Instructions; Storage Instructions for the Reconstituted or Diluted Product; Instructions to Avoid Harm Related to Drug Handling and Administration; and Additional Comments.