FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because…

fda-agency-news June 26, 2025

CARVYKTI

For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inh…

fda-agency-news June 26, 2025

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends …

fda-agency-news June 26, 2025

Unique Device Identifier Requirements for Combination Products

Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products…

fda-agency-news June 26, 2025

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends …

fda-agency-news June 26, 2025

Conducting Remote Regulatory Assessments Questions and Answers

Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry

fda-agency-news June 26, 2025

mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following …

fda-agency-news June 26, 2025

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