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.

10/5/2023	Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff
10/4/2023	Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”; Guidance for Industry
10/4/2023	October 3, 2023 Approval Letter - RabAvert
10/4/2023	BR220665 - HEMANEXT ONE
10/2/2023	September 29, 2023 Approval Letter - JYNNEOS
10/2/2023	Complete List of Licensed Products and Establishments Updated as of 9/30/2023
10/2/2023	Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 9/30/2023
10/2/2023	Complete List of Currently Approved Premarket Approvals (PMAs) Updated as of 9/30/2023
10/2/2023	Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 9/30/2023
9/30/2023	Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
9/30/2023	Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
9/30/2023	Biological Product Deviation Reporting -- Blood Product Codes
9/30/2023	General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
9/30/2023	Instructions for Using the eBPDR System
9/29/2023	Dear Healthcare Provider Letter - Warning Regarding Use of Probiotics In Preterm Infants
9/29/2023	CBER Cures Vacancy Announcement - Research Chemist, AD-1320-Band D, Office of Vaccines Research and Review (OVRR), Division of Bacterial Parasitic and Allergenic Products (DBPAP), Lab of Bacterial Polysaccharides (LBP)
9/29/2023	CBER Cures Vacancy Announcement - IT Project Manager, AD-2210-Band D, Office of Regulatory Operations (ORO), Division of Information Technology (DIT), Technology Integration and Delivery Branch (TIDB)
9/28/2023	Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry
9/28/2023	CBER Cures Vacancy Announcement – Physician, AD-0602-Band C, Office of Therapeutic Products (OTP)
9/28/2023	CBER Cures Vacancy Announcement - Lead Program Analyst, AD-0343-Band C, Office of Management (OM), Division of Acquisitions and Budget Resources (DABR), Budget Planning and Execution Branch (BPEB)
9/27/2023	September 25, 2023 Clinical Memo - GLASSIA
9/25/2023	September 22, 2023 Approval Letter - COMIRNATY
9/22/2023	Voluntary Lot Withdrawal of Allergenic Extract – Pecan nut (Carya illinoinensis) – For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results
9/21/2023	September 11, 2023 Clinical Review - SPIKEVAX
9/21/2023	September 11, 2023 Statistical Review - SPIKEVAX
9/21/2023	Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop
9/21/2023	Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry
9/21/2023	User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
9/20/2023	September 11, 2023 Clinical Review Memo - COMIRNATY
9/20/2023	Statistical Review - COMIRNATY
9/20/2023	Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards
9/20/2023	Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1); Draft Guidance for Industry
9/19/2023	Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry
9/18/2023	Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence; Draft Guidance for Industry
9/15/2023	2023 Biological License Application Approvals Updated through 8/31/2023
9/15/2023	2023 Biological Device Application Approvals Updated through 8/31/2023
9/15/2023	Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry
9/15/2023	Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry
9/14/2023	OTP Learn Updated: Overview of Office of Therapeutic Products (OTP) Regulated Products video
9/14/2023	Clinical Reviewer - ALBUMINEX
9/14/2023	Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff
9/14/2023	September 12, 2023 Summary Basis for Regulatory Action - ABRYSVO
9/13/2023	Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program Updated: FDA will begin accepting requests to participate in year two of the CDRP on October 2, 2023.
9/13/2023	September 11, 2023 Approval Letter - BIVIGAM
9/13/2023	September 11, 2023 Approval Letter - ASCENIV
9/11/2023	September 11, 2023 Approval Letter - SPIKEVAX
9/11/2023	September 11, 2023 Approval Letter COMIRNATY
9/11/2023	Warrior Families: Advancing Regenerative Medicine Through Science
9/11/2023	CBER Vacancy: Staff Fellow/Visiting Associate – Parasitic Diseases
9/11/2023	Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products; Guidance for IRBs and Clinical Investigators
9/11/2023	BK230961 - AQUIOS CL Flow Cytometer and AQUIOS Stem Kit
9/8/2023	Center for Biologics Evaluation and Research Patient Engagement Program Updated to include additional resources
9/8/2023	OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products Updated to include the event recording.
9/7/2023	Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff
9/7/2023	Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff
9/7/2023	Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement
9/6/2023	DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry
9/6/2023	Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks Linked to a Bone Matrix Product
9/6/2023	Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff
9/6/2023	Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
9/6/2023	Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff
9/5/2023	Clinical Pharmacology Review - ATGAM