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...
2 min read
The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased scrutiny on Chemistry, Manufacturing, and Controls (CMC) to operational challenges at the U.S. Food and Drug Administration (FDA), sponsors must be prepared to...
4 min read
Effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.
5 min read
The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in oncology research. A well-planned MRCT can be an efficient approach to the global clinical development of a novel product, allowing for access to a wider...
3 min read
The decision to partner with a Clinical Research Organization (CRO) is never taken lightly—especially in oncology. With high complexity, accelerated timelines, and evolving regulatory expectations, the stakes in oncology drug development are uniquely...
3 min read
Data Monitoring Committees (DMCs) play a vital role in clinical trials by providing independent oversight to ensure patient safety, maintain scientific validity, and uphold data integrity. With clinical trials becoming increasingly complex, especially...
3 min read
A growing number of biotech firms are questioning their long-standing strategy of initiating clinical trials in the U.S. first, as the Food and Drug Administration (FDA) continues to struggle with internal upheaval and reductions in staffing, leading to...
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...