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In today’s regulatory climate, ongoing discussion about FDA workload, funding constraints, and shifting review priorities have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At...
1 min read
The FDA’s Oncology Center of Excellence (OCE) is shifting the paradigm in cancer treatment development with Project FrontRunner— an initiative designed to encourage drug sponsors to develop, test, and seek approval of new cancer drugs for advanced or...
2 min read
Complex therapeutic development requires deep integration across clinical, regulatory, statistical, and operational functions. Whether optimizing dose, navigating regulatory pathways, or accelerating timelines, early and sustained collaboration is...
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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
2 min read
Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs have evolved from a basic electronic substitute for paper to a robust, standardized...
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Medical writing plays an essential role in clinical development and regulatory approval. As scientific advancements grow more complex, well-structured documentation ensures the success of clinical trials, facilitates regulatory review, and accelerates...
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In today’s increasingly complex clinical research environment, sponsors must strike a careful balance between scientific rigor, regulatory readiness, and patient engagement. The goal is not simply to move faster—but to do so with greater efficiency,...
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Many sponsors underestimate how much support the Food and Drug Administration (FDA) can offer during early drug development, often believing they need more data than is truly required before engaging. But once your proof-of-concept data, clinical...
2 min read
Clinical Impact, Technology Innovation, and Emerging Advances in Cell and Vaccine-Based Oncology
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Historically, oncology drug development followed a straightforward principle: identify the highest dose patients could tolerate without unacceptable side effects, then use that dose in subsequent trials and clinical practice. This maximum tolerated dose...