Updated January 30, 2026
- Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH
- FDA's Transition from QSR to QMSR
- ClinicalTrials.gov Modernized Website
- Office Hours
- Recent FDA Guidance
Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH
On January 29th, the National Institute of Health (NIH) released a notice updating their clinical trial policy. Per the notice (NOT-OD-26-032), basic experimental studies involving humans (BESH) no longer meet the NIH definition of a clinical trial (effective for applications submitted to due dates on or after May 25, 2026). More information can be found on the NIH website.
FDA's Transition from QSR to QMSR
The Food and Drug Administration (FDA) is transitioning from the Quality System Regulations (QSR) to Quality Management System Regulations (QMSR) and the changes will be effective on February 2nd, 2026. The regulations will still fall under the same part within the code of regulations (21 CFR 820). The new QMSR will incorporate ISO 13485 and clause 3 of ISO 9000. Additionally, multiple other FDA regulations will be updated to reflect the changes from QSR to QMSR. More information about the proposed changes can be found on the following websites:
- Quality Management System Regulation: Final Rule
- Federal Register: Quality System Regulation Amendments
ClinicalTrials.gov Modernized Website
The ClinicalTrials.gov Protocol Registration and Results System (PRS) site is undergoing a modernization effort, and the modernized site will be the default site when users log in on Wednesday, August 28th.
What is not changing?
- There is no change to the ClinicalTrials.gov regulations or related policies. The same information is required to be submitted within the same time frames according to the regulations, NIH policy, and Georgia Tech's policy.
- Your log-in information will remain the same.
Office Hours
The Office of Regulatory Affairs and Clinical Trials holds virtual office hours on Wednesdays from 1:00 to 2:00. Please use the following link join for a one on one discussion.
Join Office Hours (Wednesdays 1:00 - 2:00)
Recent FDA Guidance
The Food and Drug Administration (FDA) continuously releases guidance documents to inform the public of the Agency's current thinking on a particular subject. These guidance documents are not binding, but are considered to be best practice. Please see the current list of the Final and Draft Guidance on the FDA's website.