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.

7/05/2023	OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products
7/03/2023	June 30, 2023 Approval Letter - DENGVAXIA
7/03/2023	June 30, 2023 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
7/03/2023	June 30, 2023 Approval Letter - Flublok Quadrivalent
7/03/2023	June 30, 2023 Approval Letter - Afluria (trivalent) and Afluria Quadrivalent
7/03/2023	June 30, 2023 Approval Letter - FLUAD QUADRIVALENT
6/30/2023	Staff Fellow/Visiting Associate – Chemistry Manufacturing and Controls (CMC) Reviewer
6/30/2023	June 30, 2023 Approval Letter - ROCTAVIAN
6/29/2023	Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry
6/29/2023	June 28, 2023 Approval Letter - LANTIDRA
6/28/2023	Principal Investigator: Molecular Biologist with Bioinformatics experience
6/28/2023	Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff
6/28/2023	BK220791 - e-Delphyn Donor
6/27/2023	Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements; Guidance for Industry
6/27/2023	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2023 Updated June 27, 2023
6/27/2023	BK220798 - NexSys PCS Plasma Collection System with ExpressPlus Technology
6/26/2023	BK230820- Erytra Eflexis
6/23/2023	Clinical Review Memo - Thrombin-JMI
6/23/2023	June 21, 2023 Summary Basis for Regulatory Action - ELEVIDYS
6/23/2023	May 31, 2023 Summary Basis for Regulatory Action - ABRYSVO
6/22/2023	Summary Of Safety and Effectiveness Data - RECELL Autologous Cell Harvesting Device
6/22/2023	June 22, 2023 Approval Letter - ELEVIDYS
6/21/2023	June 12, 2023 Summary Basis for Regulatory Action - Elecsys HIV Duo
6/21/2023	June 16, 2023 Approval Order - RECELL Autologous Cell Harvesting Device (Model Number AVRL0102)
6/20/2023	June 16, 2023 Approval Letter - IDELVION
6/16/2023	June 7, 2023 Approval Letter - RECELL Autologous Cell Harvesting Device
6/16/2023	Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023
6/16/2023	June 16, 2023 Approval Letter - Thrombin-JMI
6/15/2023	Industry (Biologics)
6/15/2023	June 14, 2023 Approval Letter - BOOSTRIX
6/14/2023	June 13, 2023 Approval Letter - Elecsys HIV Duo
6/14/2023	Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
6/13/23	June 9, 2023 Clinical Review - AFSTYLA
6/13/23	June 9, 2023 Statistical Review - AFSTYLA
6/13/2023	CBER Cures Vacancy Announcement - Physician, AD-0602-Band C, Office of Vaccines Research and Review (OVRR), Division of Vaccines and Related Product Applications (DVRPA)
6/13/2023	CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Oncology Branch 2 (OB2)
6/13/2023	CBER Vacancy: Principal Investigator: Molecular Biologist with Bioinformatics experience
6/13/2023	BK220668 - VorFat System
6/12/2023	June 9, 2023 Approval Letter - AFSTYLA
6/12/2023	June 9, 2023 Approval Letter - FEIBA
6/12/2023	June 9, 2023 Approval Letter - MenQuadfi
6/9/2023	Virtual Meeting June 20, 2023: Decentralized Clinical Trials (DCT) Draft Guidance
6/9/2023	FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers - June 20, 2023
6/09/2023	Summary Basis for Regulatory Action - VYJUVEK
6/07/2023	Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff
6/7/2023	Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Guidance for Industry
6/02/2023	April 27, 2023 Clinical Review - Prevnar20
6/02/2023	April 27, 2023 Statistical Review - Prevnar20
6/02/2023	Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry
6/2/2023	Complete List of Licensed Products and Establishments Updated as of 5/31/2023
6/2/2023	Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 5/31/2023
6/2/2023	Complete List of Currently Approved Premarket Approvals (PMAs) Updated as of 5/31/2023
6/2/2023	Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 5/31/2023
6/1/2023	May 31, 2023 Approval Letter - ABRYSVO
6/1/2023	CBER Vacancy: Staff Fellow/Visiting Associate – Molecular Virologist
5/30/2023	May 26, 2023 Approval Letter - Reagent Red Blood
5/26/2023	Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry
5/26/2023	Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop Recordings now available
5/26/2023	Study Data Technical Conformance Guide - Technical Specifications Document; Guidance for Industry
5/25/2023	May 3, 2023 Summary Basis for Regulatory Action - AREXVY
5/25/2023	May 25, 2023 Approval Letter - VAXNEUVANCE
5/25/2023	Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry
5/25/2023	May 1, 2023 Clinical Review Memo - ATGAM
5/24/2023	May 22, 2023 Untitled Letter - AT Venture Center for Global Techtrepreneurship, LLC dba Regenerelle, LLC
5/23/2023	May 22, 2023 Approval Letter - SHINGRIX
5/22/2023	CBER Cures Vacancy Announcement – Clinical Pharmacologist Reviewer, AD-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH), Benign Hematology Branch (BHB)
5/19/2023	May 19, 2023 Approval Letter - VYJUVEK
5/19/2023	CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)
5/18/2023	Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry
5/17/2023	April 7, 2023 Statistical Review Memo - HYQVIA
5/17/2023	April 7, 2023 Clinical Review Memo - HYQVIA
5/17/2023	BK230807 - Adaptive Autologous Processing System
5/17/2023	Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act; Draft Guidance for Industry
5/15/2023	BK220779 - Capture Positive Control Cell