The system of drug regulation is obsolete. To keep patients around the world safe, authorities like the FDA must step up and deal with disruptive trends – without suffocating innovation.
Innovation in medicine is getting faster while the processes the US Food and Drug Administration (FDA) uses are sometimes decades old. The Patient Engagement Advisory Committee, launched in September 2015, was a great step forward. But regulators are unprepared for some big changes on the horizon.
Here are the top five issues that I believe will shape the future of the regulatory environment.
1) Patients taking action
If regulations don’t support the trends and technologies that make lives better, patients will take action themselves. This trend is already apparent, fueled by disruptive technologies like crowdsourcing. There is a chance that patients (or clusters of patient groups) might start acquiring/launching biotech companies to develop drugs and conduct clinical trials themselves…
View original post 655 more words