What's New at CBER 08/04/2023 U.S. Food and Drug Administration sent this bulletin at 08/04/2023 07:10 PM EDT What's New at CBER 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: 08/04/2023 BEACATS External User Guide-How to Enter a Certificate of a Pharmaceutical Product Application Updated BEACATS External User Guide - Modify a Pharmaceutical Product Application Step-by-step Instructions Updated BEACATS External User Guide- Search for a Certificate of a Pharmaceutical Product Application Step-by-Step Instructions Updated CBER-Regulated Products: Permanent Discontinuations lyophilized allergenic venom extract Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry Device Submissions for CBER-Regulated Products Upcoming CBER Meetings August OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy ProductsAugust 30, 2023 September Cellular, Tissue, and Gene Therapies Advisory Committee Meeting September 27, 2023 AnnouncementSeptember 27, 2023 November Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) StandardsNovember 7, 2023
