What’s New for Biologics

Latest News from the Center for Biologics Evaluation and Research at FDA

Items related to biologics will be added to the top of the list as they are posted on the site.

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2/12/2024	Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry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in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry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)