> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bioavailability Studies Guidance Comments
- URL: https://www.fdaweb.com/bioavailability-studies-guidance-comments/
- Published: 2019-05-30T12:00:00.000Z
- Updated: 2026-09-15T01:29:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144228

Merck [says](https://www.regulations.gov/document?D=FDA-2018-D-4367-0010&ref=fdaweb.com) it would be helpful if FDA would include in a draft guidance on bioavailability studies submitted in NDAs or INDs the reason or trigger for revising the 3/2014 draft guidance and a summary of key changes from the 2014 document.

Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://www.regulations.gov/document?D=FDA-2018-D-4367-0011&ref=fdaweb.com) it supports agency publication of the draft guidance and appreciates the transparency in FDA’s thinking about the requirements for conducting bioavailability studies and the information FDA expects sponsors to submit to support an application. “PhRMA believes the draft guidance will help further ensure the quality of bioavailability studies,” the letter says, “improve the consistency of study analysis provided in INDs and NDAs, and aid evaluation of drug safety and effectiveness.”

Both stakeholders also submitted specific, line-by-line comments.