| 9/18/2024 |
eSubmitter Application History |
| 9/18/2024 |
Information About the Updated COVID-19 Vaccines |
| 9/17/2024 |
Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants
October 25, 2024 |
| 9/16/2024 |
CBER Title 21 Vacancy Announcement - Information Technologist (IT Project Manager), AD-2210-D, Office of Regulatory Operations (ORO), Division of Information Technology (DIT), Program Management and Analysis Branch (PMAB)
Closes: September 27, 2024 |
| 9/16/2024 |
CBER Title 21 Vacancy Announcement - Lead Consumer Safety Officer, AD-0696-D, Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing and Products Quality (DMPQ), Manufacturing Review Branch (MRB)
Closes: October 4, 2024 |
| 9/13/2024 |
Important Information for Blood Establishments Regarding the Oropouche Virus and Blood Donation |
| 9/13/2024 |
2024 Center for Biologics Evaluation and Research (CBER) Science Symposium
Event materials posted. |
| 9/12/2024 |
September 11, 2024 Approval Letter - HEPLISAV-B |
| 9/12/2024 |
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications; Guidance for Industry |
| 9/11/2024 |
Key Facts About Vaccines to Prevent Mpox Disease |
| 9/11/2024 |
Formal Meetings and Requests for Feedback for CBER-Regulated Products
Updated |
| 9/10/2024 |
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties |
| 9/10/2024 |
CBER Title 21 Vacancy Announcement - Associate Director for Rare Diseases and Special Populations, AD-0602-Band G, Office of the Center Director (OCD)
Closes: September 20, 2024 |
| 9/10/2024 |
CBER Title 21 Vacancy Announcement - Senior Regulatory Health Project Manager (Rare Diseases), AD-0601-Band D, Office of the Center Director (OCD)
Closes: September 20, 2024 |
| 9/9/2024 |
September 9, 2024 Approval Letter - PENBRAYA |
| 9/9/2024 |
SOPP 8404: Refusal to File Procedures |
| 9/6/2024 |
September 6, 2024 Approval Letter - SPIKEVAX |
| 9/6/2024 |
August 30, 2024 Approval Letter - MENVEO |
| 9/5/2024 |
Statistical Review - ACAM2000 |
| 9/5/2024 |
August 22, 2024 Clinical Review Memo - ACAM2000 |
| 9/4/2024 |
Complete List of Licensed Products and Establishments
Update |
| 9/4/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 9/4/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 9/4/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 9/4/2024 |
CBER Title 21 Vacancy Announcement - Consumer Safety Officer, AD-0696-C, Office of Compliance and Biologics Quality (OCBQ), Division of Inspections and Surveillance (DIS), Program Surveillance Branch (PSB)
Closes: September 18, 2024 |
| 9/3/2024 |
August 30, 2024 Approval Letter - ABRYSVO (STN 125769/3) |
| 9/3/2024 |
August 16, 2024 Approval Letter - KYMRIAH |
| 9/3/2024 |
BK241042 - Illuminate PRP |
| 9/3/2024 |
CBER Title 21 Detail/Temporary Promotion Vacancy Announcement – Lead Physician, Band D, Office of Therapeutic Products, Office of Clinical Evaluation, Division of Clinical Evaluation General Medicine, General Medicine Branch 2
Closes: October 31, 2024 |
| 8/30/2024 |
2024 Center for Biologics Evaluation & Research (CBER) Science Symposium Agenda |
| 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 |
| 8/23/2024 |
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 |
