| 1 min read
Register for free to listen to this article
Listen with Speechify
0:00
1:00
SILVER SPRING, Md.—Just about everything seems to shift in terms of priorities, rules and limitations when it comes to the unfolding pandemic, so it should come as no surprise that U.S. FDA guidelines are a moving target as well.
 
In the latest development, the FDA has updated its guidance for performing clinical trials during the COVID-19 pandemic, and in that guidance the agency offers clarifications for managing protocol deviations and amendments. It also outlines the steps companies can take when they are considering patients getting experimental products at home instead of trial sites.
 
Finally, the updated guidance also contains three new questions and answers about the use of  video conferencing for remote participant visits, for utilization of alternate laboratory or imaging centers, and regarding post-marketing requirements for medical devices and treatments. Interestingly about the first of those three items, the FDA reports that it does not consider this kind of video conferencing to fall under the category of electronic records that are subject to 21 CFR part 11, but rather as “a live exchange of information between the personnel and trial participants.”
 
For more details, go to the FDA website at www.fda.gov and look for the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” document that was first issued in March 2020.

Related Topics

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

Reliable fluid biomarkers strategies for clinical neuroscience research

Reliable fluid biomarkers strategies for clinical neuroscience research

Explore how validated fluid biomarker assays advance clinical research for neurological diseases.
A group of blue capsules is scattered on a bright yellow surface, with one capsule opened to reveal white powder inside.

Understanding drug impurities: types, sources, and analytical strategies

Unseen and often unexpected, drug impurities can slip in at every drug development stage, making their detection and control essential.
Laboratorian with a white coat and blue gloves pipettes green liquid into a beaker with multicolored liquids in beakers and tubes in the blue-tinged, sterile laboratory background.

Discovering cutting-edge nitrosamine analysis in pharmaceuticals

New tools help researchers detect and manage harmful nitrosamine impurities in drugs such as monoclonal antibodies.
Drug Discovery News March 2025 Issue
Latest IssueVolume 21 • Issue 1 • March 2025

March 2025

March 2025 Issue

Explore this issue