The U.S. FDA has withdrawn several guidances relating to biologics during the course of 2024. These include:
- Emergency Use Authorization for Vaccines to Prevent COVID-19
- Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products
- Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency
- Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components
- Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances –
- Guideline for the Uniform Labeling of Blood and Blood Components
- Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1
- Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (“High Risk” Donors)
- Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin)
- Recommended Methods for Blood Grouping Reagents Evaluation
- Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin
- Guideline for Quality Assurance in Blood Establishments
- Screening and Testing of Donors of Human Tissue Intended for Transplantation
- Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products
- Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing
The full list can be found here.