Yesterday, we announced a new research collaboration with the U.S. Food and Drug Administration (FDA) that will explore how patient-reported data can lead to new insights about drug safety. It’s the first time the FDA will analyze patient-generated data for pharmacovigilence (aka drug safety). But we’re no strangers to drug safety. Check out some of… Continue reading Sally Okun explains the new research collaboration with the FDA
Tag: Administration
PatientsLikeMe and the FDA Sign Research Collaboration Agreement
WASHINGTON D.C., June 15, 2015—PatientsLikeMe and the U.S. Food and Drug Administration (FDA) have signed a research collaboration agreement to determine how patient-reported data can give new insights into drug safety. Under the collaboration, PatientsLikeMe and the FDA will systematically explore the potential of patient-generated data to inform regulatory review activities related to risk assessment… Continue reading PatientsLikeMe and the FDA Sign Research Collaboration Agreement
Sally Okun reports back from the FDA Patient-Focused Drug Development Public Meeting on IPF
On September 26th I was at the FDA for the Patient-Focused Drug Development Public Meeting on IPF. This is one of 20 meetings that the FDA is holding to learn directly from patients and their caregivers about daily life with the specific condition’s symptoms and treatments. (You can learn more about these meetings here.) I have attended… Continue reading Sally Okun reports back from the FDA Patient-Focused Drug Development Public Meeting on IPF