| 12/5/2024 |
Important Information for Blood Establishments Regarding Cybersecurity Resiliency |
| 12/4/2024 |
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff |
| 12/4/2024 |
December 2, 2024 Approval Letter - JIVI |
| 12/4/2024 |
CBER Title 21 Vacancy Announcement- Artificial Intelligence Specialist- AD-301-E- Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). Office of Regulatory Operations (ORO), Immediate Office of the Director (IOD)
Closes: December 17, 2024 |
| 12/3/2024 |
Hurricane Helene: Baxter's manufacturing recovery in North Carolina |
| 12/3/2024 |
PREHEVBRIO
Voluntarily withdrawn from the market by the company. |
| 11/27/2024 |
November 7, 2024 Summary Basis for Regulatory Action - AUCATZYL |
| 11/27/2024 |
FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel) |
| 11/26/2024 |
Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry |
| 11/25/2024 |
November 25, 2024 Approval Letter - JYNNEOS |
| 11/22/2024 |
CBER Title 21 Vacancy Announcement - Business Informaticist (Data Integration), AD-0301-D, Office of Regulatory Operations (ORO), Division of Informatics (DI), Regulatory Information Branch (RIB)
Closes: December 6, 2024 |
| 11/21/2024 |
November 20, 2024 Approval Letter - REGENECYTE |
| 11/21/2024 |
November 21, 2024 Approval Letter - PENBRAYA |
| 11/19/2004 |
Workshop on Integration Site Analysis During Long Term Follow-Up for Gene Therapies with Integrating Viral Vectors
Updated to include recording. |
| 11/18/2024 |
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry |
| 11/14/2024 |
November 13, 2024 Approval Letter - KEBILIDI |
| 11/13/2024 |
November 8, 2024 Approval Letter - WILATE |
| 11/13/2024 |
BK241075 - Atellica IM HIV Ag/Ab Combo (CHIV) |
| 11/12/2024 |
BK241132 - Elecsys Syphilis, Elecsys Anti-CMV, cobas pro serology solution |
| 11/12/2024 |
2024 Biological License Application Supplement Noteworthy Approvals
Updated as of 10/31/2024 |
| 11/12/2024 |
2024 Biological Device Application Approvals
Updated as of 10/31/2024 |
| 11/12/2024 |
CBER Title 21 Vacancy Announcement - Division Director, AD-0602-Band F, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH)
Closes: December 20, 2024 |
| 11/8/2024 |
November 8, 2024 Approval Letter - AUCATZYL |
| 11/7/2024 |
BK241097 - Rika Plasma Donation System (42000) |
| 11/6/2024 |
Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases
Polling results are available in docket FDA-2024-N-3208 at Regulations.gov. |
| 11/6/2024 |
November 5, 2024 Approval Letter - Measles, Mumps, and Rubella Virus Vaccine Live |
| 11/6/2024 |
November 5, 2024 Approval Letter - ProQuad |
| 11/6/2024 |
CBER Title 21 Vacancy Announcement - Branch Chief (Supervisory Physician), Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH), Malignant Hematology Branch (MHB)
Closes: December 20, 2024 |
| 11/5/2024 |
Finding Your Support Team While Participating in a Clinical Trial
Updated to include the recording of the webinar |
| 11/4/2024 |
Split Real Time Application Review (STAR)
FDA Pilot to Review Original Applications Following STAR Paradigm |
| 11/4/2024 |
CBER Title 21 Vacancy Announcement- Lead Physician (Team Lead), AD-0602-Band D, Office of Therapeutic Products (OTP), Division of Clinical Evaluation Hematology (DCEH), Benign Hematology Branch (BHB)
Closes: December 16, 2024 |
