2/12/2025 | Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year Data as of December 31, 2024 |
2/12/2025 | CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year Data as of December 31, 2024 |
2/12/2025 | CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals Data as of December 31, 2024 |
1/17/2025 | CY 2024 Report from the Director |
1/16/2025 | Thimerosal and Vaccines |
1/16/2025 | December 18, 2024 Summary Basis for Regulatory Action - RYONCIL |
1/15/2025 | BK231018 - AHC Platelet Concentrate Separator |
1/15/2025 | BK241148 - cobas pro serology solution (applicable to) a) Elecsys Syphilis and b) Elecsys Anti-CMV |
1/15/2025 | January 8, 2025 Summary Basis for Regulatory Action - Automated C3d Plate |
1/15/2025 | BK210601 - Echo Lumena |
1/15/2025 | BK210604 - Complement Control Cells |
1/15/2025 | BK210608 - Galileo Echo |
1/15/2025 | Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry |
1/14/2025 | Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER |
1/13/2025 | Premarket Approval Application and Humanitarian Device Exemption Modular Review; Guidance for Industry and Food and Drug Administration Staff |
1/13/2025 | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff |
1/13/2025 | Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Guidance for Industry and Food and Drug Administration Staff |
1/10/2025 | December 19, 2024 Summary Basis for Regulatory Action - SYMVESS |
1/10/2025 | Clinical Investigator Status (Biologics) Updated through 12/31/2024 |
1/10/2025 | January 8, 2025 Approval Letter - Automated C3d Plate |
1/8/2025 | Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry and Other Interested Parties |
1/8/2025 | WCBP 2025: The 29th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products January 28 - 30, 2025 |
1/8/2025 | Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry |
1/8/2025 | Considerations for Complying with 21 CFR 211.110; Draft Guidance for Industry |
1/8/2025 | Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry |
1/7/2025 | January 6, 2025 Approval Letter - AREXVY |
1/7/2025 | FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy |
1/7/2025 | January 6, 2025 Approval Letter - ABRYSVO (125769/388) |
1/6/2025 | Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry |
1/6/2025 | 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 |
1/6/2025 | 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 |
1/6/2025 | 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 |
1/6/2025 | Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry |
1/6/2025 | Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry |
1/6/2025 | BK241067 – MatchX |
1/3/2025 | December 18, 2024 Clinical Pharmacology Memorandum - NUWIQ |
1/3/2025 | Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry |
1/2/2025 | Complete List of Licensed Products and Establishments Update |
1/2/2025 | Complete List of Substantially Equivalent 510(k) Device Applications Update |
1/2/2025 | Complete List of Currently Approved Premarket Approvals (PMAs) Update |
1/2/2025 | Complete List of Currently Approved NDA and ANDA Application Submissions Update |
1/2/2025 | SOPP 8422: Processing and Review of Trans-BLA Submissions |
1/2/2025 | Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2025 |
12/31/2024 | Advanced Manufacturing Technologies Designation Program; Guidance for Industry |
12/27/2024 | Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry |
12/26/2024 | December 23, 2024 Approval Letter - MRESVIA |