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.

10/27/2023	October 27, 2023 Approval Letter - BOOSTRIX
10/27/2023	October 27, 2023 Approval Letter - KINRIX
10/27/2023	October 27, 2023 Approval Letter - INFANRIX
10/26/2023	CBER Cures Vacancy Announcement - Deputy Office Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Immediate Office of the Director (IOD)
10/26/2023	October 16, 2023 Summary Basis for Regulatory Action - Elecsys HTLV-I/II
10/25/2023	Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Draft Guidance for Industry
10/24/2023	Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry
10/23/2023	Important Information About Directed Blood Donations that are Not Medically Indicated
10/20/2023	October 20, 2023 Approval Letter - PENBRAYA
10/20/2023	2023 Biological License Application Approvals Updated as of 9/30/2023
10/20/2023	2023 Biological License Application Supplement Noteworthy Approvals Updated as of 9/30/2023
10/20/2023	2023 Biological Device Application Approvals Updated as of 9/30/2023
10/19/2023	Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
10/19/2023	Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry
10/18/2023	Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry
10/18/2023	October 17, 2023 Approval Letter - ZOLGENSMA
10/18/2023	Transcript for the FDA CBER OTP Listening Meeting: Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
10/17/2023	October 17, 2023 Approval Letter - COMIRNATY
10/17/2023	October 17, 2023 Approval Letter - Elecsys HTLV-I/II
10/17/2023	Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry
10/16/2023	CBER Cures Vacancy Announcement - Lead Program Analyst, AD-0343-Band C, Office of Management (OM), Division of Acquisition and Budget Resources (DABR), Acquisition Management Branch (AMB)
10/13/2023	Clinical Investigator Status (Biologics) Updated
10/13/2023	Investigational COVID-19 Convalescent Plasma; Guidance for Industry Updated as of 10/13/2023
10/11/2023	eSubmitter Application History Version 3.73.00 - Released 10/06/2023
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
9/28/2023	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)
9/27/2023	September 25, 2023 Clinical Memo - GLASSIA