Regulatory Affairs: Important News and Updates

Updated May 4, 2023

Page Contents:

  1. New Single Sign-On (SSO) Requirement for CITI Training
  2. FDA's Guidance for Clinical Trials During COVID-19 Pandemic
  3. FDA Emergency Use Authorizations
  4. Recent FDA Guidance


New Single Sign-On (SSO) Requirement for CITI Training

Effective May 8th, 2023: To access the CITI training website, all users (both GT and non-GT) will need to use the GT Single Sign-On (SSO) process. GT users will need to use this link to access CITI. Non-GT users will have to use an existing GT affiliation in CITI or will have to request a GT guest account so they can obtain CITI access and affiliate with GT. To request a guest account, please go to the Responsible Conduct of Research website and click "Submit Request for Georgia Tech CITI Access."


FDA's Guidance for Clinical Trials During COVID-19 Pandemic

The Food and Drug Administration (FDA) has released guidance on how clinical trials shall be conducted during the COVID-19 pandemic. Please CLICK HERE to read the guidance and see how this may impact your clinical trial.


FDA Emergency Use Authorizations

The FDA can authorize the use of an unapproved medical products or the unapproved use of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.  These Emergency Use Authorizations (EUAs) have to be requested from the FDA and have strict guidelines.  More information in regards to how to apply and guidance for EUAs can be found on the FDA’s website.  Additionally, a list of current and terminated EUA's can also be found on the FDA's website. If you intend to apply for an EUA or utilize an existing EUA, please contact the Regulatory Affairs Office as soon as possible.


Recent FDA Guidance

The Food and Drug Administration (FDA) continuosly 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 Guidances on the FDA's website.