FDA Approved Nearly All Expanded Access Requests in FY2016
By Michael Mezher -
Published 20 March 2017
The US Food and Drug Administration (FDA) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week.
Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics
Tags: Expanded Access, Compassionate Use, Right-To-Try
Trump Signals Support for 'Right-to-Try' Movement
By Michael Mezher -
Published 02 February 2017
In a meeting with pharmaceutical industry executives on Tuesday, President Donald Trump expressed his concern that the US Food and Drug Administration (FDA) is standing in the way of terminally ill patients accessing unapproved drugs as treatments of last resort.
Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics, Government affairs
Tags: Trump, Right-to-Try
Congressional Hearings Focus on Compassionate Use, FDA Issues
By Zachary Brennan -
Published 25 February 2016
Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety here), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA).
Categories: News, US, FDA, Crisis management, Drugs, Ethics, Government affairs, Medical Devices, Postmarket surveillance, Research and development, Submission and registration
Tags: Essure, compassionate use, right-to-try, Ostroff, Ted Cruz, genetic manipulation
'Right to Try' Legislation Tracker
By Alexander Gaffney, RAC -
Published 24 June 2015
Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as "Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies.
Categories: News, US, CDER, Clinical, Ethics, Government affairs
Tags: Right to Try, Right-to-Try, Compassionate Use, Expanded Access
Laws Spreading That Allow Terminal Patients Access to Experimental Drugs
By Michelle Andrews, Kaiser Health News -
Published 19 November 2014
Earlier this month, Arizona voters approved a referendum that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year.
Categories: News, US, FDA, Clinical, Ethics
Tags: Right-to-Try, Compassionate Use, Expanded Access, Kaiser Health news