What’s New for Biologics

Items related to biologics will be added to the top of the list as they are posted on the site.

12/4/2023	December 1, 2023 Approval Letter - Wilate
12/01/2023	December 1, 2023 Approval Letter - ODACTRA
11/30/2023	November 9, 2023 Summary Basis for Regulatory Action - ADZYNMA
11/30/2023	November 29, 2023 Approval Letter - Fluzone
11/29/2023	COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry
11/29/2023	Warrior Families: Advancing Regenerative Medicine Through Science Webinar Transcript
11/29/2023	Warrior Families: Advancing Regenerative Medicine Through Science Presentation Slides
11/28/2023	Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry
11/28/2023	BK231004- Blood Product Questionnaire Module
11/28/2023	FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
11/27/2023	Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry (Updated November 27, 2023)
11/27/2023	November 17, 2023 Summary Basis for Regulatory Action - PENBRAYA
11/27/2023	SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
11/21/2023	CBER CURES Vacancy Announcement – Deputy Office Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Immediate Office of the Director (IOD) Updated closing date
11/20/2023	Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
11/15/2023	CBER 2023 Orphan Approvals (new BLAs) - Updated
11/14/2023	eSubmitter Application History
11/13/2023	November 9, 2023 Approval Letter - PALFORZIA
11/13/2023	CBER Cures Vacancy Announcement - Biological Regulatory Specialist, Band C, CBER/ORO/IOD/CMCT
11/09/2023	November 9, 2023 Approval Letter - ADZYNMA
11/09/2023	November 9, 2023 Approval Letter - IXCHIQ
11/7/2023	BK230840- Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV
11/7/2023	BK230986 - ePROGESA v5.0.3
11/6/2023	Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff
11/3/2023	WCBP Symposium 2024 Event date: January 23 - 25, 2024
11/3/2023	CBER Staff Fellow - Product/Chemistry, Manufacturing and Controls (CMC) Reviewer
11/2/2023	Workshop for the Identification and Standardization of Methods for Assessing Gene Therapy Product Activity and Comparability and the Evaluation of T-Cell Therapies
11/1/2023	Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
11/1/2023	Complete List of Licensed Products and Establishments Updated as of 10/31/2023
11/1/2023	Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 10/31/2023
11/1/2023	Complete List of Currently Approved Premarket Approvals (PMAs) Updated as of 10/31/2023
11/1/2023	Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 10/31/2023
11/1/2023	CBER Cures Vacancy Announcement – Division Director, AD-Band F, Office of Therapeutic Products (OTP), Office of Cellular Therapy & Human Tissue CMC (OCTHT), Division of Human Tissue (DHT)
10/30/2023	October 27, 2023 Approval Letter - HAVRIX
10/30/2023	October 27, 2023 Approval Letter - ENGERIX-B
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