| 5/22/2024 |
Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement |
| 5/22/2024 |
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) |
| 5/22/2024 |
CBER Title 21 Vacancy Announcement – Interdisciplinary Scientist (Team Lead), Band D, Office of Vaccines Research and Review (OVRR), Division of Review Management and Regulatory Review (DRMRR) |
| 5/21/2024 |
Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease |
| 5/20/2024 |
BK231013 - LipoGrafter Kit |
| 5/20/2024 |
April 5, 2024 Clinical Review - CARVYKTI |
| 5/17/2024 |
April 25, 2024 Summary Basis for Regulatory Action - BEQVEZ |
| 5/17/2024 |
May 7, 2024 Statistical Review - ALTUVIIIO |
| 5/17/2024 |
May 7, 2024 Clinical Review Memo- ALTUVIIIO |
| 5/16/2024 |
May 15, 2024 Approval Letter - BREYANZI |
| 5/16/2024 |
Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry
Updated: May 15, 2024 |
| 5/16/2024 |
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry
Updated: May 15, 2024 |
| 5/15/2024 |
CBER Title 21 Vacancy Announcement – Health Scientist (Quality System Regulatory Review), Band D, Office of Regulatory Operations (ORO), Immediate Office of the Director (IOD) |
| 5/15/2024 |
CBER Title 21 Vacancy Announcement – Mathematical Statistician, Band B, Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB) |
| 5/13/2024 |
CBER Title 21 Vacancy Announcement - Science Disclosure Analyst, AD-0401-Bands A/B, Office of Communication Outreach and Development (OCOD), Division of Disclosure and Oversight Management (DDOM) |
| 5/13/2024 |
Annual Summary for Fiscal Year 2023 |
| 5/10/2024 |
May 10, 2024 Approval Letter - ALTUVIIIO |
| 5/10/2024 |
May 9, 2024 Approval Letter - RabAvert |
| 5/10/2024 |
Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff |
| 5/9/2024 |
May 7, 2024 Untitled Letter - Exocel Bio, Inc. |
| 5/8/2024 |
REMS Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry |
| 5/8/2024 |
eSubmitter Application History
Updated |
| 5/7/2024 |
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Inspection Information
Updated |
| 5/3/2024 |
Transcript for the Biomarker-driven Drug Development for Allergic Diseases and Asthma Public Workshop |
| 5/2/2024 |
Complete List of Licensed Products and Establishments
Update |
| 5/2/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 5/2/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 5/2/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 5/1/2024 |
May 1, 2024 Approval Letter - ADSTILADRIN |
| 5/1/2024 |
CBER Title 21 Vacancy Announcement – Management Analyst, AD-0343-Band W/Y, Office of Management (OM), Division of Program Services (DPS), Program Services Branch (PSB) |
| 4/30/2024 |
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
Update |
| 4/30/2024 |
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels; Guidance for Industry |
| 4/26/2024 |
April 26, 2024 Approval Letter - IMOVAX RABIES |
| 4/26/2024 |
April 25, 2024 Approval Letter - BEQVEZ |
| 4/26/2024 |
Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding the Recall of Certain Saline and Sterile Water Medical Products by Nurse Assist |
| 4/26/2024 |
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, IRBs, and Clinical Investigators |
| 4/26/2024 |
BK241060 - Arthrex Thrombinator System |
