Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 11, November, 2021

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Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.

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Excerpt from pg. 3 … IRBs and New ANDAs During COVID Crisis (#2)

“As we introduced in last month’s HRR, numerous factors surrounding the COVID crisis continue to impact human subjects research projects throughout the country.

A new FDA guidance addresses such effects upon a certain type of drug studies.

The guidance is titled “Development of Abbreviated New Drug Applications [ANDAs] During the COVID-19 Pandemic — Questions and Answers.” We resume our coverage with:

As a general matter, we recommend that prospective applicants take adequate precautions and have written procedures in place to ensure safety of study subjects and staff involved in the conduct of a BE [bioequivalence] study during/after the COVID-19 public health emergency” (April, 2021, rev. September 8, 2021, p. 3; on the Web at

When COVID Interrupts a Study

[We present here the first Q&A about BE studies and the safety of human subjects in applicable clinical trials. However, we will present only a few of the guidance’s remaining 14 Q&As since most involve details on biochemical manufacturing, storage, and distribution. …