3 min read
The development of innovative oncology therapies has evolved dramatically, moving beyond traditional chemotherapies to include immunotherapies, targeted agents, radiotherapies, and cell and gene therapies. As these new modalities emerge, the limitations...
3 min read
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...
1 min read
The U.S. Food and Drug Administration (FDA) is undergoing significant change. Recent announcements have highlighted budget constraints, hiring freezes, and reductions in force (RIFs) across federal health agencies, including the FDA. These shifts have...
2 min read
We’re hearing more and more about the value of radiopharmaceuticals in medicine today—but what does it take to ensure their safe and effective development throughout a clinical trial?
2 min read
Real-world evidence (RWE) offers the potential to serve as a valuable tool in regulatory decision-making, offering insights derived from the real world that can complement traditional clinical trials. By capturing data from diverse sources such as...
3 min read
Radiopharmaceuticals have been around for decades, but their role in oncology is expanding rapidly. With the increasing focus on targeted therapies, the ability to precisely deliver radiation to tumors through radiopharmaceutical therapy is becoming an...
4 min read
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...
1 min read
In the complex landscape of marketing application preparation, data analysis stands as a critical cornerstone that can either propel a submission forward or become its greatest challenge. With shifting deadlines, potential delays in data receipt, and the...
3 min read
Meet Daphne Smyth, Vice President, Global Head of Regulatory Affairs
1 min read
In the complex world of new drug applications (NDAs) and marketing authorization applications (MAAs), success often hinges not on technical expertise alone, but on how well teams work together. While each submission brings its own unique challenges, one...