Pharmaceutical Executive Daily: FDA Names Tracy Beth Høeg as Acting Director of CDER

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, the FDA appoints Tracy Beth Høeg as acting CDER director, health systems explore new commercialization partnerships for cell and gene therapies, and Aidoc submits a breakthrough-designated multi-triage AI device for FDA approval.

The FDA has appointed Tracy Beth Høeg, MD, PhD, as acting director of the Center for Drug Evaluation and Research (CDER). Hoeg steps into the role following recent leadership transitions and will guide the center’s regulatory oversight as it continues to advance policies on drug evaluation, safety, and innovation.

A new report highlights how health systems are forming innovative commercialization partnerships to support the launch and delivery of cell and gene therapies. With CGTs growing rapidly and requiring specialized infrastructure, these collaborations are aimed at improving patient access, optimizing reimbursement pathways, and ensuring sustainable long-term adoption.

In regulatory technology news, Aidoc has submitted its breakthrough-designated multi-triage AI device for FDA approval. The platform is designed to assist clinicians by detecting multiple acute conditions from medical imaging in real time, supporting faster diagnosis and improving care coordination across emergency and inpatient settings.

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