Generic Pills Allowed Limited Size Differential In Draft Guidance
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA cites concern about safety and patient adherence to therapy in draft guidance on the size, shape and other physical attributes of generic drugs.
You may also be interested in...
FDA Rejects Generic Tablets Larger Than Brand Citing Safety And Efficacy Concerns
FDA denies ANDAs for one product because the generic tablet size is larger than the brand; the agency plans to release a draft guidance on generic equivalency to the reference listed drug in size, taste and smell.
ANDA User Fees Will Fund Public Relations-focused Studies On Palatability Of Generics
One project will look at tablet size, odor and other characteristics that in the past have been a source of public complaints about generics.
Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.