Zdrowie i gospodarka · 17/06/2016
Quality Attribute Considerations for Chewable Tablets; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Quality Attribute Considerations for Chewable Tablets." This guidance describes the Agency's thinking on the critical quality attributes that should be assessed when developing a chewable tablet dosage form and recommends that the selected acceptance criteria be appropriate and meaningful indicators of product performance throughout the shelf life of the product.