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  1. News & Events (Biologics)

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.

6/07/2023 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Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry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
5/12/2023 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
5/12/2023 CBER-Regulated Products: Current Shortages
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

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