| 8/8/2023 |
June 30, 2023 Clinical Review Memo - DENGVAXIA |
| 8/8/2023 |
June 30, 2023 Statistical Review Memo - DENGVAXIA |
| 8/8/2023 |
BK230843 - Reveos Automated Whole Blood Processing System |
| 8/8/2023 |
BK230839 - Elecsys Syphilis; PreciControl Syphilis; PreciControl Release Syphilis |
| 8/4/2023 |
BEACATS External User Guide-How to Enter a Certificate of a Pharmaceutical Product Application
Updated |
| 8/4/2023 |
BEACATS External User Guide - Modify a Pharmaceutical Product Application Step-by-step Instructions
Updated |
| 8/4/2023 |
BEACATS External User Guide- Search for a Certificate of a Pharmaceutical Product Application Step-by-Step Instructions
Updated |
| 8/4/2023 |
CBER-Regulated Products: Permanent Discontinuations
lyophilized allergenic venom extract |
| 8/4/2023 |
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry |
| 8/4/2023 |
Device Submissions for CBER-Regulated Products |
| 8/2/2023 |
Complete List of Licensed Products and Establishments
Updated as of 7/31/2023 |
| 8/2/2023 |
Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 7/31/2023 |
| 8/2/2023 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Updated as of 7/31/2023 |
| 8/2/2023 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 7/31/2023 |
| 8/2/2023 |
Clinical Trials: The Patient Experience
Slides and Transcript posted. |
| 7/31/2023 |
BK230838 - IMUGARD WB PLT Platelet Pooling Set |
| 7/28/2023 |
July 27, 2023 Approval Letter - ERVEBO |
| 7/27/2023 |
BK230811 - Blood Typing Manager, version 3.0 |
| 7/27/2023 |
Cellular, Tissue, and Gene Therapies Advisory Committee Meeting September 27, 2023 Announcement |
| 7/26/2023 |
BK230835 - BD Leucocount Kit; BD FACSuite Clinical BD Leucocount Assay Module; BD FACSLyric Flow Cytometer |
| 7/26/2023 |
Clinical Investigator Status (Biologics)
Updated through 6/30/2023 |
| 7/25/2023 |
BK230826 - WellSky Transfusion 2022 R3 |
| 7/25/2023 |
OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023
Transcript added |
| 7/25/2023 |
July 13, 2023 Approval Letter - FLULAVAL QUADRIVALENT |
| 7/24/2023 |
2023 Biological License Application Approvals
Updated through 6/30/2023 |
| 7/24/2023 |
2023 Biological License Application Supplement Noteworthy Approvals
Updated through 6/30/2023 |
| 7/24/2023 |
2023 Biological Device Application Approvals
Updated through 6/30/2023 |
| 7/24/2023 |
July 21, 2023 Approval Letter - BALFAXAR |
| 7/21/2023 |
Anthrax |
| 7/21/2023 |
July 20, 2023 Approval Letter - CYFENDUS |
| 7/21/2023 |
June 28, 2023 Summary Basis for Regulatory Action - LANTIDRA |
| 7/21/2023 |
June 29, 2023 Summary Basis for Regulatory Action - ROCTAVIAN |
| 7/21/2023 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals |
| 7/21/2023 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year |
| 7/21/2023 |
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year |
| 7/20/2023 |
July 20, 2023 Approval Letter - KINRIX |
| 7/20/2023 |
July 20, 2023 Approval Letter - INFANRIX |
| 7/20/2023 |
CBER-Regulated Products: Current Shortages |
| 7/17/2023 |
CBER Cures Vacancy Announcement - Physician, AD-0602-Band C, Office of Biostatistics and Pharmacovigilance (OBPV) |
| 7/14/2023 |
Pfizer-BioNTech COVID-19 Vaccines |
| 7/14/2023 |
Coronavirus (COVID-19) | CBER-Regulated Biologics |
| 7/13/2023 |
General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
Updated
|
| 7/13/2023 |
Biological Product Deviations
Updated
|
| 7/13/2023 |
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry |
| 7/13/2023 |
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry |
| 7/12/2023 |
CBER-Regulated Products: Current Shortages |
| 7/12/2023 |
CBER Cures Vacancy Announcement – Management Analyst, AD-0343-Bands A/B, Office of Management (OM), Division of Human Capital (DHC) |
| 7/11/2023 |
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry |
