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Drug Interaction Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry |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 |