3 min read
November brought significant FDA activity, with new final and draft guidances—from Pre-RFD updates to cross-center master files and Q3E leachables—alongside notable RAPS coverage, leadership changes, regulatory developments, and multiple high-impact drug...
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...
5 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...
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...
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
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...
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...
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...
2 min read
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...
3 min read
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...