Modernization of FDA’s drug review office | Statement from FDA Commissioner Scott Gottlieb

Scientific and medical advances are giving the FDA more opportunities to more fully address diseases and illness. Whereas one time all that patients may have hoped for was the ability to control a chronic disease, and perhaps slow its advance or lessen its insidious effects, more patients today can expect the ability to arrest the march of illness or achieve an outright cure.

However, with this progress comes more complexity. Not only challenges related to the science of how drugs are discovered, but also the manner in which they’re developed. For very novel drugs targeting unmet needs, this often doesn’t follow the traditional three phases of clinical trials.

To promote the most promising opportunities and address the corresponding intricacy of these new endeavors, the FDA has introduced many fundamental advances in how it evaluates drugs for safety and effectiveness, as well as the manner in which clinical trials are guided. These include adaptive approaches to clinical development such as the introduction of seamless trial designs or master protocols or tissue agnostic product approvals. Each allow us to better marry the scientific prospect more closely to the approaches that can best unlock these opportunities.



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