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Category: FDA

Stakeholder Connect | From Guidance to Action: What Operation TrialBlazer Means for the Future of Oncology Drug Development

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In June 2026, the U.S. Department of Health and Human Services (HHS) launched a new initiative called Operation TrialBlazer to “strengthen U.S. leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.” This initiative is a department-wide effort across the U.S. Food and Drug Administration (FDA), the…

Stakeholder Connect | Insights from the July 30 Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) Meeting

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What was the committee asked to consider? On July 30, the U.S. Food and Drug Administration (FDA) convened the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) to consider data intended to support accelerated approval of a regimen combining intratumoral vusolimogene oderparepvec (RP1), a novel oncolytic immunotherapy from Replimune, and systemic nivolumab for adult patients…

Data-Driven Insights | Fast to Start, Slow to Scale: U.S. Oncology Trial Start-Up in a Global Context

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Oncology clinical trials are increasingly conducted globally, with recent trends indicating a growing share of trial activity outside of the U.S. In 2025, 80% of patients in pivotal trials supporting novel cancer drug approvals by the FDA were enrolled outside of the U.S.1 Such global trials are critical for generating data across distinct regional and…

From Innovation to Implementation: What Baby KJ Reveals About the Future of Personalized Therapies

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In 2025, an infant known as Baby KJ became one of the first patients to receive a personalized CRISPR-based gene-editing therapy, specifically designed to correct the mutation causing his life-threatening Carbamoyl phosphate synthetase (CPS1) deficiency. This rare metabolic disorder prevents the body from properly clearing ammonia which could lead to rapid toxicity and death without…

Stakeholder Connect | Insights from the April 30 Oncologic Drugs Advisory Committee (ODAC) Meeting

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What was the committee asked to consider? On April 30, 2026, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to consider the benefits and risks of two regimens for treatment of cancer.    The morning session focused on the results of the SERENA-6 trial, which was intended to support a new…

Stakeholder Connect | Insights from September 18, 2025, CBER Office of Therapeutic Products Public Listening Meeting

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The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual public listening meeting on September 18th. During this meeting, stakeholders from regulatory agencies, patient advocacy organizations, industry, and academia convened to discuss how prior knowledge and platform approaches could be better leveraged to…

Stakeholder Connect | Insights from the July 17, 2025 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

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What was the committee asked to consider?  On July 17, 2025, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to vote on whether the overall benefit-risk profile of two new combination regimens (belantamab mafodotin + bortezomib + dexamethasone [BVd] and  belantamab mafodotin + pomalidomide + dexamethasone [BPd]) for treatment…

Data Driven Insights | PDUFA at a Glance – Enabling Innovation and Timely Access to New Treatments

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As FDA and stakeholders begin preparations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), Friends of Cancer Research’s new Data Driven-Insight provides a high-level overview of the program’s history, impact, and upcoming priorities. This primer provides essential context as public discussions begin around PDUFA VIII. It also highlights how user fee programs…

Meeting Recap | Friends Annual Meeting 2024 Recap: Sharing Next Steps and Opportunities with Advocates

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On December 5, Friends of Cancer Research (Friends) hosted a public webinar, “Friends Annual Meeting 2024 Recap: Sharing Next Steps and Opportunities with Advocates,” to provide advocates with an overview of discussions from the 2024 Annual Meeting, outline the path forward, and facilitate a dialogue with the goal of capturing the community’s voice and promoting broader educational access to patient/advocacy groups.

Stakeholder Connect | Insights from First Meeting of the Digital Health Advisory Committee

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In 2023, the U.S. Food and Drug Administration (FDA) established the Digital Health Advisory Committee (DHAC) to consider topics related to the use of digital tools in drug development. On November 20 and 21st, 2024 the committee convened for the first time to discuss total product lifecycle (TPLC) considerations for generative artificial intelligence (GenAI) enabled medical devices. The establishment of the DHAC and this meeting come in response to growing interest and use of these technologies in healthcare and signal a recognition of the unique regulatory challenges presented by GenAI- and AI-enabled devices.