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The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the FDA has determined that a REMS is no longer necessary.

For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

The Andromeda galaxy, also known as Messier 31 (M31), is the closest spiral galaxy to the Milky Way at a distance of about 2.5 million light-years. This new composite image contains data of M31 taken by some…

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with…

The Host Julie Rovner KFF Health News @jrovner @julierovner.bsky.social Read Julie’s stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly…

After nearly 20 years of operations, NASA’s Mars Reconnaissance Orbiter (MRO) is on a roll, performing a new maneuver to squeeze even more science out…

For 45 years after they left military service, the Belangers relied on their private health insurance policies. Then they signed up for the VA benefits they had earned and deserved.

Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products with device constituent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

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with…

Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry