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Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry |
2/12/2024 |
CBER Title 21 Vacancy Announcement – Mathematical Statistician Team Lead, AD-1529 - Band D, Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB) |
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in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry |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 |
1/26/2024 |
Formal Meetings for CBER-Regulated Products |
1/26/2024 |
SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products |
1/25/2024 |
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Data as of December 31, 2023 |
1/25/2024 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
Data as of December 31, 2023 |
1/25/2024 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
Data as of December 31, 2023 |
1/25/2024 |
CBER Vacancy: Staff Fellow - Researcher-Reviewer |
1/24/2024 |
January 23, 2024 Safety Labeling Change Notification Letter - TECARTUS (brexucabtagene autoleucel) |
1/23/2024 |
January 16, 2024 Untitled Letter - Vitacell Biologics, LLC |
1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - ABECMA (idecabtagene vicleucel) |
1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - BREYANZI (lisocabtagene maraleucel) |
1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - CARVYKTI (ciltacabtagene autoleucel) |
1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - KYMRIAH (tisagenlecleucel) |
1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - YESCARTA (axicabtagene ciloleucel) |
1/22/2024 |
CBER Title 21 Vacancy Announcement – Physician, AD-Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation General Medicine (DCEGM), General Medicine Branch (GMB) |