FDA Guidance

“I need to breathe” — Living with Asthma: Patient Experiences, Old Challenges, New Drugs

"I need to breathe" — Living with Asthma: Patient Experiences, Old Challenges, New Drugs By Kathleen Hoffman, PhD MSPH Earlier this month, the American Lung Association (ALA), Inspire’s partner for the “Living with Asthma” online community, announced that it is looking for patient panelists to participate in a PFDD (Patient-Focused Drug [...]

What’s the FDA up to on Patient Focused Drug Development (PFDD) these days?

What’s the FDA up to on Patient-Focused Drug Development (PFDD) these days? By Kathleen Hoffman, PhD MSPH Part of the FDA’s mandate in implementing the “21st Century Cures Act” is ensuring the incorporation of patient experience data into drug development. They’ve hit the deadline for another Patient Focused Drug Development (PFDD) [...]

Looking for Guidance? FDA and PFDD at “Patients as Partners” 2019

Looking for Guidance? FDA and PFDD at "Patients as Partners" 2019 By Hannah Eccard Pujita Vaidya, Senior Advisor, Patient Focused Drug Development (PFDD) program at the Center for Drug Development and Research (CDER) at the FDA, told an audience at the Patients as Partners Conference last week that patients are the experts [...]