Search Results for Right to Try

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FDA Explains Emergency Expanded Access Application Process By Zachary Brennan - Published 18 August 2017

The US Food and Drug Administration (FDA) has laid out the process by which doctors can access an investigational drug for treatment use in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: expanded access, Right to Try, emergency IND

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

Public Citizen Warns 'Right to Try' Gives Patients False Hope By Michael Mezher - Published 06 March 2017

Advocacy nonprofit Public Citizen is calling on members of Congress to oppose several "right to try" bills, warning that the bills would undermine the US Food and Drug Administration (FDA) and provide false hope to patients.

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

Tags: Right to Try, Public Citizen

Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says By Zachary Brennan - Published 16 May 2016

The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration’s (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Crisis management, Drugs, Government affairs

Tags: compassionate use, Reagan-Udall Foundation, expanded access, right to try

FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator By Zachary Brennan - Published 07 April 2016

Patients and physicians desperate for access to a potentially life-saving investigational drug will be able to take some solace in the fact that the US Food and Drug Administration’s (FDA) nonprofit, known as the Reagan-Udall Foundation, is currently working on an online tool to help aid the process of obtaining what are known as "compassionate use" or "expanded access" treatments.

Categories: News, US, FDA, Blood, Clinical, Combination products, Crisis management, Drugs, Due Diligence, Government affairs, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: expanded access, Right to Try, compassionate use, Reagan-Udall Foundation

California Governor Vetoes Right-to-Try Bill, Points to FDA Compassionate Use Program By Zachary Brennan - Published 12 October 2015

California Gov. Jerry Brown (D) on Sunday vetoed a bill that would've allowed a pharmaceutical company to make an investigational drug available to a patient with a terminal illness on the recommendation of two physicians.

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

Tags: California, Right to Try, FDA, compassionate use

'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