Search Results for Right-to-try

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FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing By Zachary Brennan - Published 03 October 2017

The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Right-to-try, E&C Committee, Gottlieb, GAO, expanded access

FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved By Michael Mezher - Published 20 September 2017

A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Expanded Access, Compassionate Use, Right-to-Try

Who's Actually Using 'Right-To-Try' Laws? A Texas Oncologist Explains his Experience By Zachary Brennan - Published 04 August 2017

What do a former prosecutor living in Arizona and unexpectedly diagnosed with neuroendocrine tumors by a specialist at the Mayo Clinic and referred for treatment in Switzerland, a Coloradoan who was also diagnosed and referred to Switzerland for treatment, and a Los Angeles-based lawyer who tried to get into immunotherapy trials but was denied have in common? They all say they obtained treatment from a Houston-based oncology center that has extended their lives thanks to a Texas "Right-to-Try" law.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: Right to Try, Goldwater Institute, Texas Right-to-Try, Delpassand

Senate Passes 'Right-to-Try' Bill By Zachary Brennan - Published 03 August 2017

The Senate on Thursday passed via unanimous consent (meaning there was not actually a vote) a bill that claims to improve terminal patients' access to experimental drugs but, if passed in the House and signed into law, may further burden and undermine the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Right-to-Try, right to try legislation, Senate right to try

White House Doubles Down on Call to Fund FDA Entirely With Industry Fees By Zachary Brennan - Published 13 July 2017

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Medical Devices

Tags: White House, Donald Trump, FDA user fees, Right-to-Try, FDA bill

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