| 8/30/2024 |
August 29, 2024 Approval Letter – ACAM2000 |
| 8/30/2024 |
CBER Title 21 Vacancy Announcement – Branch Chief, AD-0343-Band D, Office of Management (OM)
Closes: September 20, 2024 |
| 8/29/2024 |
August 29, 2024 Approval Letter – ELEVIDYS |
| 8/29/2024 |
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff |
| 8/29/2024 |
August 28, 2024 Approval Letter – COMIRNATY |
| 8/27/2024 |
BK241081 – Blood Product Administration Module (BPAM 4-2023) |
| 8/26/2024 |
August 23, 2024 Approval Letter – MACI |
| 8/26/2024 |
CBER Title 21 Vacancy Announcement – Program Analyst, AD-0343-Bands A/B – Planning, Performance, and Formulation Branch (PPFB), Division of Management Planning and Analysis (DMPA), Office of Management (OM)
Closes: September 3, 2024 |
| 8/23/2024 |
Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff |
| 8/23/2024 |
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff |
| 8/23/2024 |
Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff |
| 8/22/2024 |
August 22, 2024 Approval Letter – SPIKEVAX |
| 8/22/2024 |
August 21, 2024 Approval Letter – AREXVY |
| 8/21/2024 |
BK241080 – ImmuLINK (v3.2) |
| 8/20/2024 |
August 19, 2024 Approval Letter – BEXSERO |
| 8/20/2024 |
Vaccines and Related Biological Products Advisory Committee Meeting Announcement
September 20, 2024 |
| 8/19/2024 |
August 13, 2024 Approval Order – INTERCEPT Blood System for Plasma |
| 8/19/2024 |
August 1, 2024 Summary Basis for Regulatory Action – TECELRA |
| 8/19/2024 |
CBER Title 21 Vacancy Announcement – Physician, Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)
Closes: November 30, 2024 |
| 8/14/2024 |
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry |
| 8/14/2024 |
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry |
| 8/14/2024 |
July 31, 2024 Clinical Review Memo-FIBRYGA |
| 8/14/2024 |
July 31, 2024 Statistical Review Memo-FIBRYGA |
| 8/14/2024 |
August 5, 2024 Approval Letter – ADSTILADRIN |
| 8/13/2024 |
Staff Fellow – Researcher-Reviewer
Closes: November 30, 2024 |
| 8/12/2024 |
Title 21 Vacancy Announcement – Consumer Safety Officer, AD-0696-A/B, Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing and Product Quality (DMPQ)
Closes: August 30, 2024 |
| 8/9/2024 |
2024 Center for Biologics Evaluation and Research (CBER) Science Symposium |
| 8/8/2024 |
BK231025 – Aptima HIV-1 Quant Dx Assay |
| 8/7/2024 |
Demographic Data Summaries for CBER Novel Biological Approvals by Year |
| 8/7/2024 |
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
Update |
| 8/7/2024 |
August 6, 2024 Approval Letter – FluMist |
| 8/7/2024 |
CBER-Regulated Products: Resolved Shortages
Rho(D) Immune Globulin (Human) |
| 8/6/2024 |
CBER 2024 Orphan Approvals (new BLAs) |
| 8/6/2024 |
Vaccines for Children – A Guide for Parents and Caregivers |
| 8/6/2024 |
Joint FDA Workshop: Developing vaccines for fungal diseases: Coccidioidomycosis/Valley fever – August 13 &14, 2024
Draft Agenda available. |
| 8/6/2024 |
FDA CBER OTP Town Hall: CMC Readiness for Gene Therapy BLAs, June 4, 2024
Town Hall transcript available. |
| 8/5/2024 |
BK241074 – SeCore CDx HLA Sequencing System |
| 8/2/2024 |
CBER Vacancy: Staff Fellow – Product/Chemistry, Manufacturing and Controls (CMC) Reviewer
Closes: October 31, 2024 |
| 8/2/2024 |
CBER Vacancy: Staff Fellow/Visiting Associate – Parasitic Diseases
Closes: September 1, 2024 |
| 8/2/2024 |
August 1, 2024 Approval Letter – TECELRA |
| 8/2/2024 |
CBER-Regulated Products: Resolved Shortages
Coagulation Factor VIIa (Recombinant) |
| 8/2/2024 |
OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
Question submission date extended through Tuesday, August 6th. |
| 8/2/2024 |
Complete List of Licensed Products and Establishments
Update |
| 8/2/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 8/2/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 8/2/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 8/1/2024 |
Statistical Review – PALFORZIA |
| 8/1/2024 |
July 23, 2024 Clinical Review Memo – PALFORZIA |
| 8/1/2024 |
July 31, 2024 Approval Letter – FIBRYNA |
| 8/1/2024 |
SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes |
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