Per a new draft guidance:While generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD), we are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors. We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates.
This is important and even more significant considering the agency’s recent proposed rule that would permit generic drug makers to update their labels if they received information about potential safety problems.
(For more on this, see here.)Next up: tighter ranges for bioequivalency