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'Orange Book' Changes? US FDA Soliciting Comments On TE Codes

 
• By Derrick Gingery

The agency wants to know if the second letter in the product equivalence ratings system is helpful and whether changes could make the information more user-friendly.

Generics
The FDA also seeks comments on the potential changes to 'Orange Book' patent listing practices. • Source: Shutterstock

Therapeutic equivalence codes could undergo an upgrade as part of the US Food and Drug Administration’s "Orange Book" modernization project.

FDA officials are soliciting public comments on the well-known “A” and “B” codes, which denote whether a drug is substitutable...

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