REGULATORY UPDATE: FDA Releases 2022 Guidance Agenda
January 26, 2022
The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has released the guidance agenda for 2022, which includes topics CBER is considering for development during the calendar year.
In the category of “Blood and Blood Components,” CBER lists six documents, including an update to the compliance policy first planned in the 2021 agenda, expanding the title to include “Blood and Blood Component… Donor Eligibility and Source Plasma Quarantine Hold Requirements.” The list includes a new guidance for the Circular of Information, three guidance documents carried over from 2021, and the Investigational COVID-19 Convalescent Plasma guidance issued earlier this month. The six documents listed are:
- Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry (revised title).
- An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for Industry (new).
- Blood Pressure and Pulse Donor Eligibility Requirements; Compliance Policy; Draft Guidance for Industry (carried over from 2021).
- Alternative Procedures for Cold-Stored Platelets Intended for Transfusion; Draft Guidance for Industry (carried over from 2021).
- Collection of Platelets by Automated Methods; Guidance for Industry (carried over from 2021).
- Investigational COVID-19 Convalescent Plasma; Guidance for Industry (updated January 2022).
In the category of “Tissues and Advanced Therapies,” CBER plans six guidances. The list includes two new guidances and four guidances carried over from 2021. The six guidances are:
- Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry (issued as draft in 2021).
- Considerations for the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry (carried over from 2021).
- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Therapies; Draft Guidance for Industry (carried over from 2021).
- Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide; Guidance for Industry (carried over from 2021).
- Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry and Staff (new).
- Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry (new).
In the category of "Vaccines," CBER plans to reissue as a draft guidance, the "Emergency Use Authorization for Vaccines to Prevent COVID-19."
Weekly Report will include additional information as these guidances are released by FDA. Members with questions may contact regulatory@aabb.org.