Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and. Successful implementation. Keywords: Early access programs, named patient programs, patients with life-threatening diseases. Managed access encompasses a variety of regulatory approaches globally including Expanded Access Program, Named Patient Program, Autorisations Temporaires d'Utilisation patient or cohort programs, and Compassionate Use Program. Common to all is the primary objective to provide treatment to.

A patient with: • advanced disease • no approved treatment options • no appropriate clinical trial options may consider trying to get a new, unapproved drug outside of the clinical trial. Access to a scientifically-tested drug outside of a clinical trial and prior to FDA approval has many names but is most commonly referred to as compassionate use. When a drug company decides to provide access to their unapproved drug outside of the clinical trial they most commonly do it in the following two ways: Expanded Access Programs (EAP) Drug companies in the late stages of drug development including the Phase III clinical trial stage, can offer Expanded Access Programs for patients who are not able to enroll in a clinical trial. The FDA generally approves these programs if the drug has demonstrated some effectiveness against a specific cancer in the on-going clinical trials. Single Patient Access Patients who are not eligible for either clinical trials or an Expanded Access Program (if one exists) may be eligible to receive the unapproved new drug by applying for Single Patient Access. In this situation, the patient's doctor must first request permission for access to the drug from the drug company. If the company agrees, the patient's doctor works with the drug company to apply for FDA approval for use of the drug for the patient.

The timeline for Single Patient Access varies. In an emergency, the FDA can walk the paperwork through in 24 hours. Check Meeting FDA Requirements for Single Patient Access for more details on the Single Patient Access process. Cautionary Notes • Prepare to be confused: There are several regulatory mechanisms (programs) along with multiple terms and definitions that are used to describe how a patient may get access to an unapproved new drug outside of a clinical trial. We will define terms used on this web site but we want you to understand that drug companies, patient advocacy organizations and the FDA may use different terms.

El Clon Download Episodes Of General Hospital. For example, the FDA terminology is specified in the FDA regulations. Most drug companies refer to their compassionate access programs with terms that are unique to their specific program and inconsistent with the FDA language. In short, the definitions and terms can be confusing. • The simplest way to get access to an unapproved drug is through a clinical trial.