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.

12/18/2023	CBER 2023 Orphan Approvals (new BLAs)
12/18/2023	CBER Vacancy: Staff Fellows – Chemistry Manufacturing and Controls (CMC) Review Scientists
12/15/2023	December 15, 2023 Approval Letter - ALYGLO
12/15/2023	SOPP 8001.4: Review of Proprietary Names for CBER Regulated Products
12/15/2023	SOPP 8301: Receipt and Processing of Master Files
12/15/2023	CBER Rare Disease Program Announcements
12/15/2023	CBER Title 21 Vacancy Announcement - Management Analyst, AD-0343-Band A/B, Office of Management (OM), Division of Human Capital (DHC), Management Services Branch (MSB)
12/14/2023	Standards Development for Regenerative Medicine Therapies Updated
12/14/2023	CBER Title 21 Vacancy Announcement – Biologist (Senior Advisor), AD-0401-Band D, Office of Regulatory Operations (ORO), Division of Regulatory Operations and Programs (DROP), Regulatory Programs Branch (RPB)
12/13/2023	Statistical Review - BIVIGAM
12/13/2023	Clinical Review Memo - BIVIGAM
12/13/2023	BK231015 - Reveal G4 Rapid HIV-1/2 Antibody Test
12/13/2023	Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry
12/13/2023	eSubmitter Application History
12/12/2003	CBER 2023 Orphan Approvals (new BLAs)
12/12/2023	December 11, 2023 Approval Letter - TECARTUS
12/12/2023	December 8, 2023 Summary Basis for Regulatory Action - IXCHIQ
12/12/2023	December 11, 2023 Approval Letter - Wilate
12/12/2023	CBER Title 21 Vacancy Announcement – Branch Chief, Band D, Office of Regulatory Operations (ORO), Division of Information Technology (DIT), Program Management and Analysis Branch (PMAB)
12/11/2023	Clinical Pharmacology Review - Wilate
12/11/2023	Statistical Review - Wilate
12/11/2023	December 8, 2023 Approval Letter - BIVIGAM
12/11/2023	CBER Title 21 Vacancy Announcement - Division Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Division of Review Management and Regulatory Review (DRMRR)
12/8/2023	Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry
12/8/2023	December 8, 2023 Approval Letter - CASGEVY
12/8/2023	December 8, 2023 Approval Letter - LYFGENIA
12/6/2023	CBER Cures Vacancy Announcement - Physician (Hematology/Oncology) AD-0602-Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)
12/4/2023	December 1, 2023 Approval Letter - Wilate
12/01/2023	December 1, 2023 Approval Letter - ODACTRA
11/30/2023	November 9, 2023 Summary Basis for Regulatory Action - ADZYNMA
11/30/2023	November 29, 2023 Approval Letter - Fluzone
11/29/2023	COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry
11/29/2023	Warrior Families: Advancing Regenerative Medicine Through Science Webinar Transcript
11/29/2023	Warrior Families: Advancing Regenerative Medicine Through Science Presentation Slides
11/28/2023	Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry
11/28/2023	BK231004- Blood Product Questionnaire Module
11/28/2023	FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
11/27/2023	Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry (Updated November 27, 2023)
11/27/2023	November 17, 2023 Summary Basis for Regulatory Action - PENBRAYA
11/27/2023	SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
11/21/2023	CBER CURES Vacancy Announcement – Deputy Office Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Immediate Office of the Director (IOD) Updated closing date
11/20/2023	Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff