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  1. News & Events (Biologics)

What’s New for Biologics

Latest News from the Center for Biologics Evaluation and Research at FDA

Items related to biologics will be added to the top of the list as they are posted on the site.

11/1/2024 Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer
Closes: January 31, 2025
11/1/2024 Transcript for the FDA CBER OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
11/1/2024 Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding the Oropouche Virus and HCT/P Donation
11/1/2024

Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases
Extended deadline for requests to make oral presentations

11/1/2024 CBER Title 21 Vacancy Announcement – Physician (Transfusion Medicine), AD-0602-Band C, Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD)
Closes: December 2, 2024 (Closing date changed)
10/31/2024 October 30, 2024 Approval Letter - RabAvert
10/30/2024 CBER Title 21 Vacancy Announcement - Health Communication Policy Analyst, AD-0601-Bands A/B, Office of Communication, Outreach and Development (OCOD), Division of Disclosure and Oversight Management (DDOM), Congressional Oversight Branch (COB)
Closes: November 13, 2024
10/29/2024 Important Information on Use of Unapproved Human Immunodeficiency Virus (HIV) Blood Sample Self-Collection Kits
10/28/2024 BK241061 - bexWISE API v1.0
10/25/2024 OTP Town Hall: Best Practices for Regulatory Interactions with OTP
10/24/2024 CBER-Regulated Products: Current Shortages
Albumin (Human)-kjda
10/24/2024 CBER-Regulated Products: Current Shortages
Immune Globulin Intravenous (Human)
10/24/2024 Vaccines and Related Biological Products Advisory Committee Meeting Announcement
December 12, 2024
10/23/2024 October 22, 2024 Approval Letter - ABRYSVO (STN125769/225)
10/23/2024 Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases
10/22/2024 September 27, 2024 Clinical Review Memo - VISTASEAL
10/22/2024 September 27, 2024 Statistical Review Memo - VISTASEAL
10/22/2024 October 18, 2024 Approval Letter - JYNNEOS
10/22/2024 Drug Interaction Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry
10/21/2024 Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) Lot 5859955 through April 1, 2025 and 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) Lot 6040410 through September 1, 2025
10/21/2024 October 18, 2024 Approval Letter - AREPANRIX
10/18/2024 Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry
10/18/2024 CBER-Regulated Products: Current Shortages
plasminogen, human-tvmh
10/17/2024 Public Safety Notification on Amniotic Fluid Eyedrops
October 17, 2024 Update
10/17/2024 Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry
10/17/2024 Clinical Investigator Status (Biologics)
Updated
10/17/2024 Recommendations 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
10/16/2024 October 15, 2024 Approval Letter - Flublok
10/15/2024 CBER Title 21 Vacancy Announcement - Consumer Safety Officer, AD-0696-A/B, Office of Compliance and Biologics Quality (OCBQ), Division of Inspections and Surveillance (DIS), Bioresearch Monitoring Branch (BMB)
Closes: November 1, 2024
10/11/2024 SOPP 8402: Designation of Amendments as Major
10/10/2024 October 10, 2024 Approval Letter - COMIRNATY
10/10/2024 CBER Title 21 Vacancy Announcement – Physician (Transfusion Medicine), AD-0602-Band C, Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD)
Closes: November 4, 2024
10/9/2024 2024 Center for Biologics Evaluation and Research (CBER) Science Symposium
Transcripts and recordings available.
10/9/2024 CBER Cures Vacancy Announcement – Office Director, AD-0401-Band G, Office of Therapeutic Products (OTP), Office of Pharmacology/Toxicology (OPT)
Closes: November 8, 2024
10/4/2024 October 3, 2024 Approval Letter - MRESVIA
10/2/2024 October 1, 2024 Approval Letter - Octaplas
10/2/2024 Complete List of Licensed Products and Establishments
Update
10/2/2024 Complete List of Substantially Equivalent 510(k) Device Applications
Update
10/2/2024 Complete List of Currently Approved Premarket Approvals (PMAs)
Update
10/2/2024 Complete List of Currently Approved NDA and ANDA Application Submissions
Update
10/2/2024 Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry
10/2/2024 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting Announcement
November 21, 2024
10/1/2024 September 27, 2024 Approval Letter - VISTASEAL
10/1/2024 Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
10/1/2024 Biological Product Deviation Reporting - Blood Product Codes
10/1/2024 Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes


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