Simplifying Global Compliance
The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs
ANDA Sponsors’ Tablets/Capsules Should Hew Close to RLD in Size, Shape
Dec. 13, 2013
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. The agency says it wants the drugmakers to be sure that in producing a generic they are not changing the product shape in a way that will lead to medication errors or reduce medication compliance by making pills difficult to swallow.
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