Tag: guidance

FDA Issues First of Four Draft Guidances Related to Patient-Focused Drug Development

Today, the U.S. Food and Drug Administration (FDA) released guidance titled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (Guidance 1), to address how stakeholders can collect and submit patient experience data from patients, caregivers, clinicians and patient advocacy groups for product development and regulatory decision-making. “Patient experience data” is defined as data that is “collected by […]

Lawmakers Call to Clarify HHS’ Mobile Medical App Regulation

The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and Accountability Act’s (HIPAA) application to app developers that collect and use sensitive personal data. In response to […]