| 3/15/2024 |
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff |
| 3/15/2024 |
March 14, 2024 Approval Letter - GARDASIL 9 |
| 3/14/2024 |
March 12, 2024 Untitled Letter - Amnion Florida, LLC |
| 3/14/2024 |
BK231035 - Rika Plasma Donation System (V2.1) |
| 3/13/2024 |
2024 Biological License Application Approvals
Updated as of 2/29/2024 |
| 3/13/2024 |
2024 Biological Device Application Approvals
Updated as of 2/29/2024 |
| 3/13/2024 |
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff |
| 3/13/2024 |
CBER Cures Vacancy Announcement - Lead Physician, AD-0602-Band D, Office of Therapeutic Products (OTP), Division of Clinical Evaluation Hematology (DCEH), Benign Hematology Branch (BHB) |
| 3/12/2024 |
Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry |
| 3/12/2024 |
CBER Vacancy: Staff Fellow/Visiting Associate – Interdisciplinary Scientist |
| 3/11/2024 |
February 28, 2024 Summary Basis for Regulatory Action - Elecsys Anti-HCV II |
| 3/11/2024 |
Blood Products Advisory Committee May 9, 2024 Meeting Announcement |
| 3/11/2024 |
CBER Title 21 Vacancy Announcement – Lead Program Analyst, Band C, Center for Biologics Evaluation and Research (CBER), Office of Management (OM), Division of Management and Planning Analysis (DMPA), Capacity Planning and Management Analysis Branch (CPMAB) |
| 3/8/2024 |
February 15, 2024 Summary Basis for Regulatory Action - AMTAGVI |
| 3/7/2024 |
CBER 2024 Orphan Approvals |
| 3/7/2024 |
February 26, 2024 Summary Basis for Regulatory Action - Elecsys Anti-HBc II |
| 3/7/2024 |
February 21, 2024 Summary Basis for Regulatory Action - Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm |
| 3/7/2024 |
CBER Title 21 Vacancy Announcement – Mathematical Statistician, AD-1529-Band D, Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB) |
| 3/5/2024 |
Use of Trivalent Influenza Vaccines for the 2024-2025 U.S. Influenza Season |
| 3/5/2024 |
March 1, 2024 Approval Letter - YESCARTA |
| 3/5/2024 |
Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement
Updated: March 5, 2024 |
| 3/5/2024 |
CBER Title 21 Vacancy Announcement – Deputy Division Director, AD-0601-Band E, Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Bacterial Parasitic and Allergenic Products (DBPAP) |
| 3/4/2024 |
February 29, 2024 Approval Letter - Kedbumin |
| 3/4/2024 |
March 1, 2024 Approval Letter - AFLURIA |
| 3/4/2024 |
Summary of Safety and Probable Benefit (SSPB) - QUELIMMUNE |
| 3/4/2024 |
March 1, 2024 Approval Letter - BIVIGAM |
| 3/4/2024 |
March1, 2024 Approval Letter - ASCENIV |
| 3/4/2024 |
Complete List of Licensed Products and Establishments
Update |
| 3/4/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 3/4/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 3/4/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 3/1/2024 |
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry |
| 3/1/2024 |
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards |
| 3/1/2024 |
Information for Health Professionals on “Partial Heart Transplantation" |
| 2/29/2024 |
February 28, 2024 Approval Letter - ESPEROCT |
| 2/29/2024 |
February 28, 2024 Approval Letter - Elecsys Anti-HCV II |
| 2/28/2024 |
February 21, 2024 Approval Letter - Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm |
| 2/28/2024 |
February 23, 2024 Untitled Letter - Oregon Medical Centers, LLC |
| 2/27/2024 |
February 27, 2024 Approval Letter - Elecsys Anti-HBc II |
| 2/26/2024 |
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry |
| 2/26/2024 |
CBER Cures Vacancy Announcement - Science Disclosure Analyst, AD-0401-Band A/B, Office of Communication Outreach and Development (OCOD), Division of Disclosure and Oversight Management (DDOM) |
| 2/23/2024 |
February 21, 2024 Approval Letter - QUELIMMUNE |
| 2/22/2024 |
BK231016 - Aeon ACKit |
| 2/22/2024 |
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry and Food and Drug Administration Staff |
| 2/22/2024 |
February 16, 2024 Approval Letter - AMTAGVI - updated 2/22/24 |
| 2/22/2024 |
CBER Cures Vacancy Announcement - Division Director, AD-0602-Band F, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE) |
| 2/21/2024 |
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry |
| 2/20/2024 |
SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments |
| 2/16/2024 |
February 1, 2024 Summary Basis for Regulatory Action - Elecsys Chagas |
| 2/16/2024 |
SOPP 8413: Postmarketing Requirement/Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting |
| 2/16/2024 |
Fast Track Designation Request Performance
Updated as of 1/31/2024 |
| 2/16/2024 |
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) |
| 2/15/2024 |
Charging for Investigational Drugs Under an IND: Questions and Answers; Guidance for Industry |
| 2/15/2024 |
February 14, 2024 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent Southern Hemisphere |
