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.

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Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry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Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry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Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act; Draft Guidance for Industry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
5/12/2023	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 Update
5/12/2023	CBER-Regulated Products: Current Shortages Update
5/12/2023	May 11, 2023 Approval Letter - Adacel
5/11/2023	DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Covered COVID-19 Products
5/11/2023	Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry
5/11/2023	Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
5/11/2023	May 8, 2023 Approval Letter - HEPLISAV-B
5/10/2023	May 9, 2023 Approval Letter - SPIKEVAX
5/9/2023	Recombinant Protein-Based COVID-19 Vaccines Workshop Updated with a recording of the event.
5/9/2023	April 26, 2023 Summary Basis for Regulatory Action - VOWST
5/9/2023	eSubmitter Application History Update
5/4/2023	Formal Meetings for CBER-Regulated Products
5/4/2023	Vaccines and Related Biological Products Advisory Committee Meeting June 15, 2023 Announcement
5/4/2023	CBER-Regulated Products: Resolved Shortages
5/4/2023	Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products Updated with links to Zoom recordings
5/3/2023	May 2, 2023 Approval Letter - Kcentra
5/3/2023	May 2, 2023 Approval Letter - ATGAM
5/3/2023	Complete List of Licensed Products and Establishments Updated as of 4/30/2023
5/3/2023	Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 4/30/2023
5/3/2023	Complete List of Currently Approved Premarket Approvals (PMAs) Updated as of 4/30/2023
5/3/2023	Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 4/30/2023
5/2/2023	Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders
5/2/2023	CBER Cures Vacancy Announcement - Lead Physician (Hematology), AD-0602-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)
5/2/2023	CBER Cures Vacancy Announcement - Physician (Hematology), AD-0602-Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)