Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point
Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.
You may also be interested in...
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.
EveryLife Foundation study finds inpatient and outpatient care, not prescription drugs, are the primary excess medical costs associated with rare diseases.
Industry groups, along with many rare disease and patient advocacy groups, appear behind the acting commissioner getting the permanent position.