Update der Übersicht über kommende Leitfäden des CBER in 2024

In regelmäßigen Abständen veröffentlicht das Center for Biologics Evaluation and Research (CBER) der FDA eine Übersicht über die im laufenden Geschäftsjahr geplanten Neuerscheinungen von Leitlinien in Bereichen, in denen aktuell noch keine Dokumente existieren, über Leitlinien, die existieren, aber jetzt überarbeitet werden sollen und über Leitlinien, von denen bereits Entwürfe existieren und die nach Evaluierung der eingegangenen Kommentare nun fertiggestellt werden können. Die Liste stellt eine Planung dar, eine Absichtserklärung, ist aber nicht bindend und es können sowohl Themen vorläufig wegfallen als auch Leitlinien zu anderen Themen bearbeitet werden.

Nachfolgend finden Sie eine Übericht über die genannten Leitfäden. In diesem speziellen Fall haben wir die englsichen Originaltitel beibehalten, um Missverständnisse und Übersetzungsfehler zu vermeiden:

Kategorie Blut und Blutkomponenten

• Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry
• Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry
• Collection of Platelets by Automated Methods; Draft Guidance for Industry
• Blood Pressure and Pulse Donor Eligibility Requirements; Compliance Policy; Guidance for Industry
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry
• Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry

Kategorie Therpeutische Produkte

• Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry (Published 1/30/2024)
• Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry (Published 1/30/2024)
• Frequently Asked Questions — Cell and Gene Therapy Products; Draft Guidance for Industry
• Considerations for the Use of Human- and Animal- Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry (Published 4/30/2024)
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry (Published 4/30/2024)
• Accelerated Approval of Human Gene Therapy Products for Rare Diseases; Draft Guidance for Industry
• Use of Platform Technologies in Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry
• Potency Assessment of Therapeutic Vaccines; Draft Guidance for Industry
• Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
• Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
• Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
• Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
• Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry

Kategorie Andere:

• Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions (Published 6/5/2024)

Die vollständige Originalagenda des CBER finden Sie auf der FDA Webseite.