Search Results for Expanded Access

Showing 1 – 25  of 25

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

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

GAO: FDA Improved Expanded Access but More Clarity Necessary By Zachary Brennan - Published 11 July 2017

With the rise of Right-to-Try legislation across  the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: expanded access, compassionate use, GAO reports, adverse events

Sanofi, CDC and FDA Work to Avoid Yellow Fever Vaccine Shortage By Michael Mezher - Published 01 May 2017

To head off an impending shortage of YF-VAX, the only US-licensed vaccine for yellow fever, Sanofi Pasteur, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are working to provide travelers with an alternative vaccine.

Categories: News, Africa, Latin America and Caribbean, US, FDA, Biologics and biotechnology

Tags: Yellow Fever, Expanded Access, Sanofi Pasteur, YF-VAX, Stamaril

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

FDA Looks to Revitalize Compassionate Use Program With Simplified Form, Final Guidance By Zachary Brennan - Published 02 June 2016

The US Food and Drug Administration (FDA) on Thursday finalized two question and answer guidance documents on charging for investigational drugs and expanded access for the compassionate use of investigational drugs for those with life-threatening diseases or conditions, as well as a new streamlined form for applying for expanded access.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: compassionate use, expanded access, access to investigational drug, access to drug in clinical trials

FDA Official Dispels ‘100 Hours’ Myth on Time it Takes to Fill Out Compassionate Use Form By Zachary Brennan - Published 17 May 2016

The simplification of the US Food and Drug Administration’s (FDA) compassionate use process (announced last February and expected to be finalized very soon) may not actually be all that much of a simplification in terms of the amount of time it takes a physician to fill out the form, an FDA official told Focus on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Research and development

Tags: compassionate use, expanded access, Form 1571, Goldwater Institute, Form 3926

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

FDA Expanded Access Pathways By Rachelle D'Souza - Published 16 November 2015

This article discusses the various US regulatory pathways for access to investigational drugs and medical devices outside a clinical trial.

Categories: Features, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy

Tags: Expanded Access

'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

From 100 Hours to 1: FDA Dramatically Simplifies its Compassionate Use Process By Alexander Gaffney, RAC - Published 04 February 2015

In response to repeated criticism that terminally ill patients find it too difficult to obtain access to experimental and potentially life-saving drugs, the US Food and Drug Administration (FDA) has announced changes to its "compassionate use" process in the hopes of making it easier for physicians to request access to medical products on behalf of their patients.

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

Tags: Expanded Access, Compassionate Use, Form FDA 1571, Form FDA 3926, Draft Guidance, Guidance

Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program By Alexander Gaffney, RAC - Published 04 February 2014

In our latest Regulatory Explainer, we break down FDA's expanded access-sometimes referred to as compassionate use-regulations to understand how they work.

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

Tags: Investigational IND, Early Access Program, Compassionate Use Program, Regulatory Explainer, Compassionate Use, IND, Expanded Access

FDA Sees 92% Increase in Requests for Compassionate Access to Medicines in 2014 By Alexander Gaffney, RAC - Published 23 January 2015

Last year, the US Food and Drug Administration (FDA) received—and approved—substantially more requests for "compassionate" access to potentially life-saving treatments than any time since at least 2010, according to new data provided by the regulator.

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

Tags: Compassionate Use, Expanded Access, IND, Investigational New Drug Application

Pharmaceutical Companies Look to Create Better Compassionate Use Process Published 11 December 2014

The prominent US pharmaceutical trade group PhRMA has released an updated set of principles it says reflects the US pharmaceutical industry's "commitment" to provide patients with life-threatening diseases access to investigational therapies on a compassionate-use basis.

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

Tags: Compassionate Use, Expanded Access, PhRMA, PhRMA Expanded Access Principles

Legislation Seeks to Overhaul FDA's Compassionate Use Program By Alexander Gaffney, RAC - Published 09 December 2014

New legislation introduced in the House of Representatives would makes changes to the US Food and Drug Administration's (FDA) "expanded access"—sometimes called "compassionate use"—policies in the hopes of making it easier for terminally ill patients to access potentially life-saving drugs.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs

Tags: Compassionate Use, Expanded Access, Legislation, Bill, House, Andrea Sloan

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

Company's Compassion Leads to Clinical Hold on Experimental Drug By Alexander Gaffney, RAC - Published 19 November 2014

If you're trying to understand why some drug companies are reluctant to allow desperate patients to enroll in their early-stage clinical trials, look no further than the case of CytRx Corporation, whose clinical trial for the drug compound aldoxorubic is now partially on hold following the death of a patient enrolled in the trial on a compassionate use basis.

Categories: News, US, CDER, Clinical

Tags: Compassionate Use, Expanded Access, Clinical Hold

Think Tank Seeks Ebola Info from FDA, Calling it a Test Case for Compassionate Use System By Alexander Gaffney, RAC - Published 09 October 2014

A libertarian-leaning think tank is pressuring the US Food and Drug Administration (FDA) to release information regarding the internal approval processes it used to permit two US citizens stricken with Ebola access to Mapp Biopharmaceuticals' ZMapp, an experimental drug.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Ethics

Tags: Ebola, Zmapp, Mapp Biopharmaceutical, Compassionate Use, Expanded Access

FDA Leverages Compassionate Use Program to Allow Access to Experimental Ebola Drug By Alexander Gaffney, RAC - Published 22 September 2014

Canadian biopharmaceutical company Tekmira has announced that the US Food and Drug Administration (FDA) will allow its investigational Ebola drug, TKM-Ebola, to be used by patients under an emergency expanded access program—a stark reversal for the product, which two months ago was subject to a complete clinical hold.

Categories: News, Africa, US, FDA, Biologics and biotechnology, Clinical, Preclinical

Tags: TKM-Ebola, Tekmira, Compassionate Use Ebola, Ebola FDA, Expanded Access Ebola

Pfizer Launches Expanded Access Program for Breast Cancer Drug By Alexander Gaffney, RAC - Published 21 August 2014

The US Food and Drug Administration's (FDA) expanded access program, sometimes referred to as its "Compassionate Use" program, has frequently been in the news as of late, as dozens of patients have taken to social media in an attempt to pressure companies into allowing them access to clinical trials they believe might save their lives. But while many companies have seemed reluctant to grant access to those trials, pharmaceutical giant Pfizer is taking a markedly different approach for a new expanded access trial for its breast cancer drug palbociclib.

Categories: News, US, Clinical, Prescription drugs

Tags: Pfizer, EAP, Expanded Access Program, Expanded Access, Breast Cancer, Compassionate Use, Palbociclib

Senators Want Detailed Data on FDA's Compassionate Use Program, Including Potential Improvements By Alexander Gaffney, RAC - Published 19 June 2014

Three Republican legislators are pressing the US Food and Drug Administration (FDA) to provide them with information about its application of its expanded access regulations, saying they are in the midst of performing "oversight" over the program.

Categories: News, US, CBER, CDER, Clinical, Government affairs

Tags: Compassionate Use, Expanded Access, Expanded Access IND, Expanded Access Protocol

In Wake of Compassionate Use Debate, New Bill Promises Wider Access to Drugs and Devices By Alexander Gaffney, RAC - Published 16 April 2014

Categories: US

Tags: Expanded Access, Compassionate Use, Legislation, House, Law, Latest News, Congress

Data Show Varied Use, Success of FDA's Expanded Access Program By Alexander Gaffney, RAC - Published 26 March 2014

Categories: US, FDA

Tags: 21 CFR 312, INDs, Expanded Access, Compassionate Use, Protocols, Latest News