The United States House of Representatives

US Legislature says FDA should use in silico methods

In an unprecedented victory for the in silico community in the US Congress has put forward a bill that “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.”

The Report also provides a definition of a kind of in silico trials which is very close to that developed in the Avicenna “Roadmap on in silico medicine”.

“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.”

That the value of in silico trials have been recognised by Congress as an important new technological development with the potential to improve the development of medicinal products and medical devices is a major policy step forward for the in silico market.

The Avicenna Alliance will be working to ensure that the European Commission is made aware of the progressive steps being taken by the US Government and encourage them to follow suit by creating a modern in silico policy framework for the EU.

The full text of the Report can be found here:

 

 

 

Sign up for our monthly newsletter!


Sign up