Drug Regulators, FDA CBER, Publish Draft Clinical Guidance for Cancer Vaccines.
This guidance provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine, recommendations on critical clinical considerations for investigational studies of these products. This guidance will discuss considerations common to phase 1 and phase 2 clinical trials (which collectively may be referred to as “early phase clinical trials”) and phase 3 clinical trials (which may be referred to as “late phase clinical trials”) and that are unique to specific stages of clinical development of these biological products.
The products discussed in this guidance are for therapeutic cancer vaccines, referred to as “cancer vaccines” throughout this document, intended to be administered to patients with an existing cancer for the purpose of treatment. This guidance does not apply to products intended to be administered to patients to prevent or decrease the incidence of cancer. Furthermore, this guidance does not apply to adoptive immunotherapeutic products such as T cell or NK cell products. Although clinical trials involving these products share certain overlapping features with those involving cancer vaccines, adoptive immunotherapeutic products have different mechanisms of action and unique requirements with respect to product development.
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Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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