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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
Selected TopicExpanded Access
In light of the growing coronavirus (COVID-19) public health challenge, the FDA issued guidance on March 18 on general considerations for conducting clinical trials of medical products during the COVID-19 pandemic.
Over the last few months, FDA has continued its efforts to encourage and facilitate the use of the agency’s Expanded Access Program (EAP). This follows other FDA EAP actions, including its announcement of program improvements.
FDA recently signaled that it plans to be more involved in facilitating expanded access to investigational new drugs. This follows the agency’s announcement of its efforts to improve and clarify the expanded access program (EAP), as well as state and federal legislation intended to simplify the process to use investigational drugs for treatment purposes.
One item that stakeholders may have missed, given the almost daily FDA developments, was the agency’s announcement that it will continue to improve and clarify its expanded access program (EAP).
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Federal Right to Try Act), signed into law on May 30, creates a federal framework for patients to access investigational new drugs without enrolling in clinical trials and without FDA expanded access approval.