USFDA-Header WHAT'S NEW AT CBER What'sNewMainImage Bookmark and Share You are subscribed to  What's New at CBER for the U.S. Food & Drug Administration (FDA) - WHAT'S NEW TODAY The following links have been updated recently: Posted: 09/22/2023 * 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 - WORKSHOPS, MEETINGS & CONFERENCES SEP September Cellular, Tissue, and Gene Therapies Advisory Committee Meeting September 27, 2023 OCT October 2023 Warrior Families Webinar October 5, 2023 Vaccines and Related Biological Products Advisory Committee Meeting October 5, 2023 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting October 31, 2023 NOV November Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards November 7, 2023 - REQUEST FOR COMMENTS DRAFT GUIDANCE ON MANUFACTURING CHANGES New draft guidance on manufacturing changes and comparability for human cellular and #GeneTherapy products. Listen to this recorded webinar for a high-level overview and submit comments to the docket by November 13, 2023: feedtwitterfacebookyoutubeflickr Manage Subscriptions  |   |  Help - This email was sent to [email protected] using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA GovDelivery logo