FDA Guidances - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products
Establishments that manufacture human cells, tissues, and cellular and tissue-based products have to comply with a number of requirements under Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). This includes Investigating and reporting adverse reactions.
Blood - Revised Recommendations for Reducing the Risk of HIV Transmission
With the new draft the US FDA wants to replace the guidance document "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," issued in 1992. Learn more about the draft Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.
Mixing, Diluting, or Repackaging Biological Products - FDA Draft Guidance
The US FDA published a draft guidance document on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application. Read more about the FDA Draft Guidance.
Revision of relevant PIC/S Guidance Documents in 2014
In 2014, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published the revision of two annexes of their GMP guide, relevant for blood and biological products. Read more about the Revision of relevant PIC/S Guidance Documents in 2014.
FDA Outlook: Guidance Documents CBER is Planning to Publish in 2015
In January CBER published an overview about the planning of the development and teh revision of guidances in the field of blood, tissues and cellular products. Read more about the Guidance Documents CBER is planning on publishing.
FDA finalizes Guidance for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
In December 2014, the Food and Drug Administration, Center for Biologics Evaluation and Research published the guidance on "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture". Read more here.
FDA publishes Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products
The FDA has published a Draft Guideline with recommendations for human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff for the criterion of minimal manipulation. Learn more.