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.

12/28/2023	Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry
12/27/2023	Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers; Guidance for Industry
12/27/2023	December 21, 2023 Approval Letter - YESCARTA
12/27/2023	CBER Title 21 Vacancy Announcement – Physician (Senior Advisor for Pediatrics), Band D, Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Clinical and Toxicology Review (DCTR)
12/27/2023	CBER Title 21 Vacancy Announcement – Physician (Senior Advisor for Therapeutics), Band D, Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Clinical and Toxicology Review (DCTR)
12/26/2023	CBER Title 21 Vacancy Announcement – Associate Director for Policy and Special Projects, AD-Band F, Office of Therapeutic Products (OTP), Policy and Special Projects Staff (PSPS)
12/26/2023	Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry
12/22/2023	December 15, 2023 Approval Letter - ALYGLO - updated
12/22/2023	December 21, 2023 Approval Letter - CARVYKTI
12/22/2023	CBER-Regulated Products: Current Shortages 6% Hetastarch in 0.9% Sodium Chloride Injection
12/22/2023	Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
12/22/2023	Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry
12/22/2023	Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
12/22/2023	Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders
12/21/2023	CBER-Regulated Products: Current Shortages Rho(D) Immune Globulin (Human)
12/21/2023	December 20, 2023 Approval Letter - HIBERIX
12/20/2023	December 19, 2023 Approval Letter -Intercept Blood System for Platelets
12/19/2023	Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
12/18/2023	SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug Applications
12/18/2023	SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications
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
12/13/2023	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
12/11/2023	Clinical Pharmacology Review - Wilate
12/11/2023	Statistical Review - Wilate
12/11/2023	December 8, 2023 Approval Letter - BIVIGAM
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