# \#regulatory

**URL:** https://discourse.datamethods.org/tag/regulatory/175.md

[Latest](https://discourse.datamethods.org/latest.md) · [Categories](https://discourse.datamethods.org/categories.md) · [Tags](https://discourse.datamethods.org/tags.md)

---

## [Communicating statistical concerns to the FDA](https://discourse.datamethods.org/t/communicating-statistical-concerns-to-the-fda/8244)

<div class="topic-metadata">

**Author:** [@feizuo](https://discourse.datamethods.org/u/feizuo)\
**Replies:** 3\
**Last updated:** [March 11, 2024, 10:26pm UTC](https://discourse.datamethods.org/t/communicating-statistical-concerns-to-the-fda/8244 "2024-03-11T22:26:45Z")

</div>

Does anyone have insight into or experience with reporting concerns to the FDA regarding their approval of drugs based on inappropriate statistical methods and endpoints, such as but not limited to comparing median perce…

---

## [Changing the "Status Quo" analyses for Regulatory Submission - Change from Baseline](https://discourse.datamethods.org/t/changing-the-status-quo-analyses-for-regulatory-submission-change-from-baseline/5725)

<div class="topic-metadata">

**Author:** [@daszlosek](https://discourse.datamethods.org/u/daszlosek)\
**Replies:** 20\
**Last updated:** [September 1, 2022, 6:03pm UTC](https://discourse.datamethods.org/t/changing-the-status-quo-analyses-for-regulatory-submission-change-from-baseline/5725 "2022-09-01T18:03:05Z")

</div>

I have been having been consulting with a company that plans to use change from baseline for the primary endpoint. I have shown them multitudes of studies (many from: Common Statistical Myth - Change) that show change f…

---

## [Anomal Pharm: Randomized good, statistical bad](https://discourse.datamethods.org/t/anomal-pharm-randomized-good-statistical-bad/5086)

<div class="topic-metadata">

**Author:** [@davidcnorrismd](https://discourse.datamethods.org/u/davidcnorrismd)\
**Replies:** 2\
**Last updated:** [November 24, 2021, 3:51pm UTC](https://discourse.datamethods.org/t/anomal-pharm-randomized-good-statistical-bad/5086 "2021-11-24T15:51:13Z")

</div>

The 2021 Friends of Cancer Research Annual Meeting Day 2 featured a panel discussion somehow connected with FDA’s #ProjectOptimus, in which the supposed importance of randomized dose-comparison studies was stressed, but …