Regulators in the US are beginning to recognise the potential for modelling and simulation technologies to improve the delivery of safe and efficacious biomedical products.
The following text is taken from the Senate Fiscal Year 2016 FDA Appropriations Bill (S. 1800) & Report (S. Rept. 114-82):
"In Silico Clinical Trials. – In Silico clinical trials use computer models and simulations to develop and assess devices and drugs, including their potential risk to the public, before being tested in live clinical trials. Advanced computer modeling may also prove useful in helping to predict how a drug or device will behave when deployed in the general population or when used in particular circumstances, thereby helping to protect the public from the unintended consequences of side effects and drug interactions. In Silico trials may potentially protect public health, advance personalized treatment, and be executed quickly and for a fraction of the cost of a full scale live trial. The FDA has advocated the use of such systems as an additional innovative research tool. Therefore, the Committee urges FDA to engage with device and drug sponsors to explore greater use, where appropriate, of In Silico trials for advancing new devices and drug therapy applications." (Source: FDA Law Blog)
Text of the Bill: https://www.congress.gov/114/bills/s1800/BILLS-114s1800pcs.xml
Text of the Report: https://www.congress.gov/114/crpt/srpt82/CRPT-114srpt82.pdf
