COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Updates Convalescent Plasma Guidelines to Announce Temporary Enforcement Discretion for Testing

FDA maze of regulations
Share on facebook
Facebook
Share on twitter
Twitter
Share on linkedin
LinkedIn
Share on pinterest
Pinterest
Share on whatsapp
WhatsApp
Share on email
Email
Share on facebook
Share on twitter
Share on linkedin
Share on google
Share on whatsapp
Share on email

Updates to FDA guidelines include enforcement discretion, allowing three months of testing flexibility for convalescent plasma as laboratories develop collection procedures

On Sept. 2, 2020, the US Food and Drug Administration (FDA) announced updates to initial convalescent plasma guidelines that became available when the emergency use authorization (EUA) for convalescent plasma was first announced. These guidelines detail temporary enforcement discretion addressing convalescent plasma that was collected prior to the issuance of the EUA. Also addressed with the update is the collection of plasma by those who are not yet able to establish the necessary operating procedures due to the time it takes to develop these procedures.

The FDA updated guidelines state, “Considering these issues and recognizing the immediate need for convalescent plasma to treat hospitalized patients with COVID-19, we intend to exercise temporary enforcement discretion regarding the [investigational new drug application] IND requirements for the use of investigational convalescent plasma.” The FDA sets forth circumstances that must be met for eligibility for temporary enforcement discretion, including:

  • The convalescent plasma is intended to treat hospitalized COVID-19 patients.
  • Informed consent must be obtained before administering investigational convalescent plasma. The FDA specifies, “Informed consent should include, at a minimum, a statement that the use of convalescent plasma is investigational and a discussion of its potential risks and benefits.”
  • The investigational convalescent plasma must be collected by registered blood establishments from donors who meet all eligibility requirements and qualifications of the FDA guidance.
  • The container label of investigational convalescent plasma must include specific language detailed in the guidance.

Enforcement discretion will be exercised for 90 days following the issuance of the updated guidance, according to the FDA. Clinical laboratory leaders wanting to learn more should read the full text of the updated guidance here.

Related Resources:

Investigational COVID-19 Convalescent Plasma: Guidance for Industry

FDA: Recommendations for Investigational COVID-19 Convalescent Plasma

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group