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.

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9/6/2023	Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff
9/6/2023	Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
9/6/2023	Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff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	CBER Vacancy: Staff Fellow/Visiting Associate - Pharmacology/Toxicology Reviewer
9/5/2023	Clinical Pharmacology Review - ATGAM
9/1/2023	Complete List of Licensed Products and Establishments Updated as of 8/31/2023
9/1/2023	Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 8/31/2023
9/1/2023	Complete List of Currently Approved Premarket Approvals (PMAs) Updated as of 8/31/2023
9/1/2023	Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 8/31/2023
8/31/2023	Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
8/30/2023	2023 PDA/ FDA Joint Regulatory Conference
8/30/2023	Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies; Guidance for Industry
8/30/2023	Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry
8/30/2023	CBER Cures Vacancy Announcement - Physician (Gastroenterology), AD-0602-Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)
8/29/2023	Vaccine Facts: Why you and your Family Need Vaccines
8/28/2023	CBER Rare Disease Program
8/25/2023	August 9, 2023 Approval Letter - ADYNOVATE
8/25/2023	Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies; Guidance for Industry
8/24/2023	Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products: An FDA Public Workshop
8/24/2023	Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting Announcement
8/24/2023	August 23, 2023 Approval Letter - ATGAM
8/23/2023	August 21, 2023 Approval Letter - VARIVAX
8/23/2023	August 21, 2023 Approval Letter - ProQuad
8/23/2023	August 21, 2023 Approval Letter - ABRYSVO (STN 125769/26)
8/21/2023	August 21, 2023 Approval Letter - ABRYSVO (STN 125768)
8/21/2023	Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry
8/18/2023	eSubmitter Application History
8/18/2023	2023 Biological License Application Approvals Updated through 7/31/2023
8/18/2023	2023 Biological License Application Supplement Noteworthy Approvals Updated through 7/31/2023
8/18/2023	2023 Biological Device Application Approvals Updated through 7/31/2023
8/16/2023	BK230844 - nSTRIDE PRP Concentration System
8/15/2023	BK230971 - IH-500
8/15/2023	CBER Cures Vacancy Announcement – Lead Physician (Hematology), AD-0602-Band D, Office of Therapeutic Products (OTP)
8/15/2023	CBER Cures Vacancy Announcement – Physician (Hematology), AD-0602-Band C, Office of Therapeutic Products (OTP), OCE
8/14/2023	July 20, 2023 Summary Basis for Regulatory Action – CYFENDUS
8/11/2023	July 19, 2023 Summary Basis for Regulatory Action - BALFAXAR
8/10/2023	Classification Categories for Certain Supplements Under BsUFA III; Draft Guidance for Industry
8/10/2023	Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products; Draft Guidance for Industry
8/9/2023	BK230833 - Access HIV Ag/Ab combo; Access HIV Ag/Ab combo Calibrators; Access HIV Ag/Ab combo QC
8/9/2023	July 27, 2022 Clinical Review Memo - ERVEBO
8/9/2023	Statistical Review and Evaluation - ERVEBO
8/8/2023	June 30, 2023 Clinical Review Memo - DENGVAXIA
8/8/2023	June 30, 2023 Statistical Review Memo - DENGVAXIA
8/8/2023	BK230843 - Reveos Automated Whole Blood Processing System
8/8/2023	BK230839 - Elecsys Syphilis; PreciControl Syphilis; PreciControl Release Syphilis