| 2/28/2024 |
February 21, 2024 Approval Letter - Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm |
| 2/28/2024 |
February 23, 2024 Untitled Letter - Oregon Medical Centers, LLC |
| 2/27/2024 |
February 27, 2024 Approval Letter - Elecsys Anti-HBc II |
| 2/26/2024 |
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide; Guidance for Industry |
| 2/26/2024 |
CBER Cures Vacancy Announcement - Science Disclosure Analyst, AD-0401-Band A/B, Office of Communication Outreach and Development (OCOD), Division of Disclosure and Oversight Management (DDOM) |
| 2/26/2024 |
Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement |
| 2/23/2024 |
February 21, 2024 Approval Letter - QUELIMMUNE |
| 2/23/2024 |
CBER Cures Vacancy Announcement - Statistician, AD-1530-Band B, Division of Biostatistics (DB), Office of Biostatistics and Pharmacovigilance (OBPV), Center for Biologics Evaluation and Research (CBER) |
| 2/22/2024 |
BK231016 - Aeon ACKit |
| 2/22/2024 |
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry and Food and Drug Administration Staff |
| 2/22/2024 |
February 16, 2024 Approval Letter - AMTAGVI - updated 2/22/24 |
| 2/22/2024 |
CBER Cures Vacancy Announcement - Division Director, AD-0602-Band F, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE) |
| 2/21/2024 |
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry |
| 2/20/2024 |
SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments |
| 2/16/2024 |
February 1, 2024 Summary Basis for Regulatory Action - Elecsys Chagas |
| 2/16/2024 |
SOPP 8413: Postmarketing Requirement/Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting |
| 2/16/2024 |
Fast Track Designation Request Performance
Updated as of 1/31/2024 |
| 2/16/2024 |
2024 Biological License Application Approvals
Updated as of 1/31/2024 |
| 2/16/2024 |
2024 Biological License Application Supplement Noteworthy Approvals
Updated as of 1/31/2024 |
| 2/16/2024 |
CBER Title 21 Vacancy Announcement – Physician (Transfusion Medicine), AD-0602-Band C, Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD) |
| 2/16/2024 |
CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH), Benign Hematology Branch (BHB) |
| 2/15/2024 |
Charging for Investigational Drugs Under an IND: Questions and Answers; Guidance for Industry |
| 2/15/2024 |
February 14, 2024 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent Southern Hemisphere |
| 2/14/2024 |
SOPP 8419: Section 505(o)(4) Required Safety Labeling Changes (SLCs) |
| 2/12/2024 |
Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry |
| 2/9/2024 |
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Guidance for Industry |
| 2/9/2024 |
SOPP 8401.2: Administrative Processing of BLA and NDA Supplements |
| 2/9/2024 |
Vaccines and Related Biological Products Advisory Committee March 5, 2024 Meeting Announcement |
| 2/8/2024 |
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry |
| 2/8/2024 |
CBER-Regulated Products: Current Shortages
Rho(D) Immune Globulin (Human) |
|
| 2/8/2024 |
CBER-Regulated Products: Current Shortages
Coagulation Factor VIIa (Recombinant) |
| 2/6/2024 |
February 5, 2024 Approval Letter - Elecsys Chagas |
| 2/5/2024 |
Conducting Remote Regulatory Assessments Questions and Answers; Draft Guidance for Industry |
| 2/5/2024 |
February 1, 2024 Approval Letter - AFLURIA |
| 2/5/2024 |
CBER Title 21 Vacancy Announcement – Physician, Band C, Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), Division of Pharmacovigilance (DPV) |
| 2/2/2024 |
Complete List of Licensed Products and Establishments
Update |
| 2/2/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 2/2/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 2/2/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 2/1/2024 |
January 26, 2024 Clinical Review Memo - GAMMAGARD LIQUID |
| 2/1/2024 |
Preclinical Pharmacology Toxicology Review - GAMMAGARD LIQUID |
| 2/1/2024 |
Statistical Review - GAMMAGARD LIQUID |
| 1/31/2024 |
January 30, 2024 Approval Letter - STRATAGRAFT |
| 1/31/2024 |
January 30, 2024 Approval Letter - ZEMAIRA |
| 1/31/2024 |
January 16, 2024 Summary Basis for Regulatory Action - CASGEVY |
| 1/30/2024 |
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry |
| 1/29/2024 |
January 26, 2024 Approval Letter - GAMMAGARD LIQUID |
| 1/29/2024 |
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024 |
| 1/29/2024 |
January 26, 2024 Approval Letter - Afluria Trivalent and Afluria Quadrivalent |
| 1/29/2024 |
Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry |
| 1/29/2024 |
Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry |
