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FDA Publishes Final Guidance on Physical Attributes of Generics

Philip Katz

Philip Katz,

Washington, D.C.

Sari Bourne

Sari Bourne,

Washington, D.C.

18 June 2015
FDA today published a final version of its guidance, “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules,” with only minor differences from the draft that was published in December 2013.  The guidance notes the potential effects of physical characteristics, and suggests that generic products not differ significantly from the reference listed drug (RLD) in this regard.  The guidance also notes the possible implications for biowaiver requests for different strengths of a proposed product.  Although there is nothing new in the final guidance, its publication is a reminder that differences from the RLD in size, shape, or other physical attributes may affect the approvability of a generic drug product.

Our blog post about the December 2013 draft guidance is available here.

Philip Katz

Philip Katz,

Washington, D.C.

Sari Bourne

Sari Bourne,

Washington, D.C.

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