Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 36, No. 11, November, 2021
Back Issues
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.
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 https://www.fda.gov/media/147355/download).
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. …““