| 7/22/2024 |
Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry |
| 7/17/2024 |
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Guidance for Industry |
| 7/16/2024 |
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024
Updated: July 15, 2024 |
| 7/16/2024 |
CBER Title 21 Job Announcement- Deputy Office Director, Series 0341, Band F, Center for Biologics Evaluation and Research (CBER), Office of Management (OM)
Closes: July 29, 2024 |
| 7/15/2024 |
June 17, 2024 Summary Basis for Regulatory Action - CAPVAXIVE |
| 7/12/2024 |
CBER Title 21- Data Scientist, AD 0301, Band D, Office of Biostatistics and Pharmacovigilance (OBPV), Division of Analytics and Benefit-Risk Assessment (DABRA), Analytics and RWE Branch (ARWEB)
Closes: July 25, 2024 |
| 7/11/2024 |
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products; Draft Guidance for Industry and FDA Staff |
| 7/11/2024 |
BK241069 - Blood Bank Information Management System (BBIMS) v3.01 |
| 7/11/2024 |
2024 CBER Patient and Care Partner Listening Meetings |
| 7/10/2024 |
June 13, 2024 Summary Basis for Regulatory Action - YIMMUGO |
| 7/10/2024 |
SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug Applications |
| 7/9/2024 |
CBER Title 21 Vacancy Announcement- Project Manager, AD 0301 Band B- Office of Biostatistics and Pharmacovigilance (OBPV), Immediate Office of the Director (IOD), CBER Surveillance Program Staff
Closes: July 22, 2024 |
| 7/8/2024 |
CBER Title 21 Vacancy Announcement – Information Technologist, AD-2210-Band C, Office of Regulatory Operations (ORO), Division of Information Technology (DIT), Technology Integration and Delivery Branch (TIDB)
Closes: July 22, 2024 |
| 7/3/2024 |
July 1, 2024 Approval Letter - AFLURIA |
| 7/2/2024 |
July 1, 2024 Approval Letter - FLUARIX |
| 7/2/2024 |
July 1, 2024 Approval Letter- Fluzone and Fluzone High-Dose |
| 7/2/2024 |
Staff Fellow/Visiting Associate – Microbiologist
Closes: August 31, 2024 (updated closing date) |
| 7/1/2024 |
July 1, 2024 Approval Letter - FLUCELVAX |
| 7/1/2024 |
July 1, 2024 Approval Letter - Flublok |
| 7/1/2024 |
July 1, 2024 Approval Letter - FLULAVAL |
| 7/1/2024 |
July 1, 2024 Approval Letter - FLUAD |
| 7/1/2024 |
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Draft Guidance for Industry |
| 6/28/2024 |
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry |
| 6/27/2024 |
June 13, 2024 Approval Letter - KYMRIAH |
| 6/26/2024 |
BK241062 - BloodTrack Software 4.16.0 |
| 6/26/2024 |
Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System |
| 6/25/2024 |
Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry |
| 6/21/2024 |
June 20, 2024 Approval Letter - SEVENFACT |
| 6/21/2024 |
Vaccines for Children - A Guide for Parents and Caregivers
Updated |
| 6/21/2024 |
CBER Title 21 Vacancy Announcement - Branch Chief, Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH), Malignant Hematology Branch (MHB)
Closes: July 19. 2024 |
| 6/20/2024 |
June 20, 2024 Approval Letter - ELEVIDYS |
| 6/20/2024 |
June 18, 2024 Integrated Clinical and Clinical Pharmacology Review Memo - ELEVIDYS |
| 6/20/2024 |
Statistical Review - ELEVIDYS |
| 6/20/2024 |
June 18, 2024 Approval Letter - TRUMENBA |
| 6/20/2024 |
CBER-Regulated Products: Current Shortages |
| 6/18/2024 |
CBER Title 21 Vacancy Announcement – Division Director, AD-0602-Band F, Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD)
Closes: July 21, 2024 |
| 6/17/2024 |
June 17, 2024 Approval Letter - CAPVAXIVE |
| 6/17/2024 |
June 14, 2024 Approval Letter - Standardized Mite Extract (Dermatophagoides farinae) |
| 6/17/2024 |
Standards Development for Regenerative Medicine Therapies
Updated |
