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An Orange Book By Any Other Name …

 
• By Derrick Gingery

One of US FDA’s most important publications ever, the Orange Book celebrates 40 years as the definitive guide to approved drug products and therapeutic equivalents. Even as the color has receded from the book itself, orange still generates appreciation from regulators and outside attorneys.

FDA Orange Book's 40th anniversary
The 27-28 October FDA conference on the Orange Book is the agency's first ever dedicated to the venerable drug reference. • Source: Pink Sheet illustration

David Rosen believes there is a red and green version of the Orange Book in his files somewhere.

The Christmas-colored edition contains the original edits Rosen and an FDA colleague made in highlighters before the agency published its first list of approved drug products and therapeutic equivalence evaluations...

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