CDER is the lead Center for regulation of human drugs that are regulated by FDA under the authority of the Federal Food Drug and Cosmetic (FD&C) Act. Drug products are defined in section 201...

This document, which supersedes all prior agreements, outlines the working relationships that exist between CBER and CDRH for certain categories of medical devices or specified medical …

Jun 4, 2020 · This compliance program focuses on inspections of combination product manufacturers (see definition in Attachment C) of CDER or CDRH-led4 single-entity and co-packaged finished combination...

IND is assigned to the review division based on the clinical indication (CDER) or type of therapy (CBER) and reviewed on a 30 day clock IND includes nonclinical data to support FTIH AND Clinical protocol

Troy Tazbaz (Director of CDRH’s Digital Health Center of Excellence) is Co-Chair of CHAI’s Government Advisory Board. The AI White Paper states that FDA plans to build on existing initiatives for evaluation and regulation of AI in medical products, including in manufacturing.

Mar 25, 2024 · These guidance documents will likely include important information on CDRH’s, CDER’s, and CBER’s current expectations for the content of premarket submissions for AI-enabled medical products or products developed using AI.

Jun 4, 2020 · In a newly issued compliance program, the US Food and Drug Administration (FDA) explains its approach to inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products.

Feb 27, 2025 · The research provides a comprehensive overview of the FDA's regulatory pathways for drug, biologic, and device approvals through its three centers—CDER, CBER, and CDRH.

Jun 12, 2020 · In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological p...

Mar 19, 2024 · Last week, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.”