With rapid developments in science, technology and new approaches to diseases, there comes a time when current regulations and policies may be suboptimal to ensure rapid and meaningful assessment, approval and access to new drugs without compromising patient safety. Nanomedicine, precision medicine, personalized medicine, advanced therapies and other innovative therapies, Big data platforms and innovative test systems in vitro, in silico for potential replacement of “established methods” are examples of challenges currently being faced. In addition, emerging diseases requiring rapid responses (e.g., the current Zika virus outbreak) and diseases that have only small patient populations (i.e., orphan diseases) may require adjusted regulations and policies or benefit from some new regulatory pathways like the PRIME. Regulatory science, the science behind regulations and policy making, is needed for and expected to provide solutions to these modern challenges.
In this broad-scope Research Topic, we welcome submissions that address the many modern challenges in regulatory science, including how to provide regulations for the treatments of orphan diseases, clinical applications of precision medicine, the development of nanomedicines, and much more. Another aspect we seek to take into consideration is how regulations can be developed to meet the demands of a globalized, interconnected world market. Of special interest are reviews and original research articles providing an overview of the current status of the field and presenting new, promising and innovative directions in regulatory science that would facilitate novel therapeutic approaches for improved patient outcomes.
With rapid developments in science, technology and new approaches to diseases, there comes a time when current regulations and policies may be suboptimal to ensure rapid and meaningful assessment, approval and access to new drugs without compromising patient safety. Nanomedicine, precision medicine, personalized medicine, advanced therapies and other innovative therapies, Big data platforms and innovative test systems in vitro, in silico for potential replacement of “established methods” are examples of challenges currently being faced. In addition, emerging diseases requiring rapid responses (e.g., the current Zika virus outbreak) and diseases that have only small patient populations (i.e., orphan diseases) may require adjusted regulations and policies or benefit from some new regulatory pathways like the PRIME. Regulatory science, the science behind regulations and policy making, is needed for and expected to provide solutions to these modern challenges.
In this broad-scope Research Topic, we welcome submissions that address the many modern challenges in regulatory science, including how to provide regulations for the treatments of orphan diseases, clinical applications of precision medicine, the development of nanomedicines, and much more. Another aspect we seek to take into consideration is how regulations can be developed to meet the demands of a globalized, interconnected world market. Of special interest are reviews and original research articles providing an overview of the current status of the field and presenting new, promising and innovative directions in regulatory science that would facilitate novel therapeutic approaches for improved patient outcomes.