February 16, 2021

CBER Guidance Agenda: What to Expect in 2021

February 16, 2021—Earlier this month, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) released the list of guidances it anticipates issuing this year. 

The list contains just 14 guidances, down significantly from the 31 CBER issued last year. Of course, this announcement only reflects the Center’s current intention. It isn’t required to issue these guidances, nor is it precluded from developing guidance documents on topics not on this list.

It projects updates to previously addressed topics as well as those that currently have no guidance associated with them. Having had a productive start to the year, CBER has already issued several of these documents—all of which are identified below with an asterisk(*). 

The plan focuses largely on two categories—blood/blood components and tissues/advanced therapies:

Blood and Blood Components

  • Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments (Q&A)
  • Blood Pressure and Pulse Donor Eligibility Requirements (Draft only)
  • Alternative Procedures for Cold-Stored Platelets Intended for Transfusion (Draft only) 
  • Collection of Platelets by Automated Methods
  • Investigational COVID-19 Convalescent Plasma*
  • Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components

Tissues and Advanced Therapies

  • Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
  • Human Gene Therapy for Neurodegenerative Diseases* 
  • Considerations for the Development of Human Gene Therapy Products Incorporating Genome Editing (Draft only)
  • Considerations for the Development of Chimeric Antigen Receptor T Cell Therapies (Draft only)
  • Studying Multiple Versions of a Cellular or Gene Therapy Product in a Clinical Trial (Draft only)
  • Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—Small  Entity Compliance Guide
  • Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency*

In addition, CBER plans to issue guidance for industry regarding Chemistry, Manufacturing, and Controls Changes to an Approved Application.

If you have questions regarding this alert or the status of any of the above guidance documents, please contact Razor Legal Solutions here.

This alert provides information as a service to clients and other friends of the firm for educational purposes only. It should not be construed or relied upon as legal advice, and it does not create an attorney-client relationship. © Razor Legal Solutions 2021