FDA Launches ‘Project Facilitate’ to Improve Access to Unapproved Cancer Therapies
The FDA Oncology Center of Excellence announced a new pilot program called Project Facilitate. Its purpose is to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer. A newly minted and dedicated call center will be the single point of contact for the pathway known as Expanded Access. This pathway is dedicated to patients with an immediately life-threatening or serious disease or condition, allowing them to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory alternative therapy options available. The FDA announcement included the following
Expanded Access is a pathway for a patient with an immediately life-threatening or serious disease or condition to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory alternative therapy options available.
A resource designed to educate patients and health care professionals about the FDA Expanded Access process. The Navigator offers information provided by companies about their Expanded Access policies and now includes Expanded Access programs listed in ClinicalTrials.gov
Phone number: 240-402-0004 (call during regular business hours, 9 a.m. to 5 p.m., Eastern Daylight Time, Monday through Friday)
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Jointly provided by
NOT ENOUGH CME HOURS
It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan