miércoles, 18 de abril de 2018

FDA issues revised draft guidance for industry - Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

FDA is announcing the availability of a draft guidance for industry entitled Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations.  MDIs and DPIs are products that deliver one or more drug substances to the site of action through the inhalation route.  Both types of products are used to treat lung diseases characterized by obstruction of airflow and shortness of breath, including asthma and chronic obstructive pulmonary disease (COPD), as well as respiratory infections and cystic fibrosis.  

The guidance describes chemistry, manufacturing, and controls (CMC) information recommended for inclusion in new drug applications (NDAs) and abbreviated new drug applications (ANDAs), as well as certain aspects with respect to labeling.  

Quality and product performance are particularly important for the potentially life-threatening conditions that these complex products are used to treat.  The information in the guidance will benefit applicants by providing clarity with respect to product development and information to submit in an application.  The guidance document’s focus on critical quality attributes can help foster a more transparent and consistent approach to product development, with improved performance that is better tailored to address consumer needs.

No hay comentarios: