Early Access to Investigational Therapy
For Physicians and Healthcare Providers
The EA Navigator helps you explore options for accessing investigational treatments. First, you must identify investigational treatments appropriate for your ...
Expanded access, also known as compassionate use, is a program that allows patients with severe or life-threatening illnesses to receive investigational ...
Pre-launch drug access programmes can help patients access investigational therapies before they receive regulatory approval and are launched ...
A Brief History of Expanded Access (Pt. 2) 2014 - 2020 - myTomorrows
Further, an important step was taken to simplify the process for physicians seeking access to an investigational product to treat their patients ...
Access to Our Therapies - Ultragenyx
For patients who are ineligible for, or unable to participate in, a clinical study and have no treatment options, our early access program may be an option.
What is an investigational therapy?
A: Both allow patients to apply for access to investigational therapies outside of clinical trials, but FDA's ... A: First, talk with your doctor. The best ...
Before It's Too Late - ASCO Publications
Compassionate use can produce data that enhance drug development for children. Introduction. Access to investigational therapies outside of a clinical trial is ...
Access to Investigational Drugs - Ferring U.S.
Enrolling in a clinical trial is the primary way for patients to access Ferring investigational drugs prior to regulatory approval.
Expanded Access Policy | ImmunoGen ADC Technology-focused ...
In general, patients obtain access to investigational agents prior to regulatory approval by participating in clinical trials. ... early access, pre-approval ...
THE PROMISE OF EARLY ACCESS PROGRAMS - COREX Logistics
Expanded Access Programs: Similar to EAPs, these programs are designed to provide access to investigational drugs for patients who do not ...
Access to Investigational Medicines | Bayer Global
You - or someone you're caring for - may be able to be treated by your doctor with an investigational medicine in certain circumstances when ...
Policy for Expanded Access to Investigational Medicines
it has been established that access to the investigational medication will not compromise future or ongoing clinical trials in a way that may delay access to ...
Expanding access to our investigational medications
However, for patients with very serious and/or life-threatening conditions who have exhausted all currently available treatment options and are ...
Early Access to Medicines Scheme | Cancer Research UK
The Early Access to Medicines Scheme (EAMS) gives people access to promising new drugs that are not yet licensed.
(PDF) Early access programs: Benefits, challenges, and key ...
EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial ...
Practical, Legal, and Ethical Issues in Expanded Access to ...
The difficulties in accessing investigational drugs have led to three primary kinds of legal challenges. First, some patients have argued that ...
Expanded access - Agomab Therapeutics
Patient enrollment in a clinical trial is not possible. ... Potential patient benefit justifies the potential risks of treatment. ... Providing the investigational ...
Karyopharm Expanded Access Program
Expanded Access Programs (also known as EAPs) provide access to an investigational clinical product outside of a clinical trial before the drug has been given ...
Expanded Access - Sapience Therapeutics
We support expanded access to our investigational medicinal products when there is substantial scientific evidence to assure both safety and efficacy. Early in ...
Leukaemia patients granted early access to investigational treatment
The MHRA Early Access to Medicines Scheme (EAMS) aims to give patients with clear unmet medical need due to a life-threatening condition such as ...