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The agency published guidance on the research and development of individualized therapies.
On Dec. 15, 2017, FDA announced it is publishing two draft guidance documents to clarify the agency’s recommendations for researching and developing target therapies. Targeted therapies are treatments tailored to the unique characteristics of a specific person’s disease. In planning its role in the advancement of targeted therapies, FDA plans on building a framework of guidance and resources. The agency will clarify and expand its existing pathway to help innovators to develop these products.
One of these new guidance documents addresses how companies can find treatments to address underlying molecular changes that cause or contribute to diseases. It proposes an approach to enroll patients in clinical trials for targeted therapies and what evidence is needed to demonstrate effectiveness for a variety of molecular subsets within a particular disease.
The other guidance document provides a framework for those running clinical trials so they may determine if an in vitro diagnostic (IVD) device must undergo FDA review. The guidance will clarify the appropriate regulatory pathway for these IVDs. According to the agency, “the aim is to make the process for developing more targeted ‘drug and diagnostics systems’ more efficient and to simplify the proper development of these approaches.”