Generic substitution of epinephrine autoinjectors: Patient and caregiver perceptions and attitudes.

Background: It is important to understand and address patient and caregiver perceptions about and attitudes toward generic substitution of drug-device combination products.

Objective: The goal of this study was to explore how differences in design and usability features of epinephrine autoinjectors (EAIs) affect patients' and caregivers' views of product quality, efficacy, and device usability in an emergency setting and to better understand attitudes about and perceptions of EAI substitution.

Methods: This qualitative, enhanced focus group study was conducted in the United States among adult and adolescent EAI users.

Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective.

Regulatory science for generic dry powder inhalers (DPIs) in the United States (U.S.) has evolved over the last decade.

Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective.

Regulatory science for generic dry powder inhalation products worldwide has evolved over the last decade. The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations [1] (Revision 1, April 2018) that FDA issued summarizes product considerations and potential critical quality attributes (CQAs). This guidance emphasizes the need to apply the principles of quality by design (QbD) and elements of pharmaceutical development discussed in the International Conference for Harmonisation of (ICH) guidelines.