mHealth and the FDA

FDA Updates Expanded Access Program to Boost Patient Experiences

November 12, 2018 - The Food & Drug Administration (FDA) is making updates to its expanded access (EA) program to improve patient experiences in the program and streamline administrative hurdles. The FDA’s expanded access program is intended for patients with a serious illness who cannot access a drug through a clinical trial. Through an application process, a patient can access experimental...

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FDA MyStudies App to Integrate Patient Data into Clinical Trials

by Sara Heath

The Food and Drug Administration has unveiled its MyStudies app, a tool aimed at collecting patient-generated health data (PGHD) and other information to inform regulatory decision-making and clinical trial development. As the healthcare...

FDA Recommits to Patient-Centered Care, Patient Access to Care

by Sara Heath

The FDA is continuing its efforts for patient-centered care, releasing two separate statements focused on incorporating patient voice into medical product development and improving patient access to affordable drugs. The first statement...

FDA, NORD Partner to Understand Patient Experiences with Care

by Sara Heath

The FDA and the National Organization for Rare Diseases (NORD) will partner to create listening sessions during which FDA can learn about patient experiences with rare disease. The program will allow patients to share their perspectives...

FDA: Medical Device Orgs Must Offer Patient Access to Health Data

by Sara Heath

FDA has issued final guidance to authorized medical device manufacturers, clarifying that it is acceptable for those manufacturers to open patient access to health data for those patients who request access. The guidance states that...

FDA Holds First Patient Engagement Advisory Committee Meeting

by Sara Heath

FDA held its first Patient Engagement Advisory Committee (PEAC) meeting on Wednesday, October 11, aiming to engage patients and caregivers in discussions regarding FDA’s regulatory activities. “The FDA’s work requires us...

FDA Plans First Patient Engagement Advisory Committee Meeting

by Sara Heath

The FDA has set a date for its first Patient Engagement Advisory Committee (PEAC) meeting, according to an agency blog post. Kathryn O’Callaghan and Jeffery Shuren, MD, JD, wrote that the meeting will take place on October 11 and 12...


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