Article Text

other Versions

PDF
21st century cure, 19th century risk

Statistics from Altmetric.com

In September 2016, the USA's Food and Drug Administration (FDA) approved a new drug for the treatment of Duchenne muscular dystrophy under its accelerated approval pathway. FDA approval was based on surrogate endpoints and, to date, no clinical benefit has been established.1 Internationally, there is considerable push to innovate therapeutics and one major feature of this is the acceleration of the process for new drug registrations, particularly in the field of cancer chemotherapy and for the management of rare diseases. In the USA, this is encapsulated in the 21st Century Cures Act currently going through the USA Senate; while in Europe, the European Medicines Agency …

View Full Text

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.