'Orange Book' Changes? US FDA Soliciting Comments On TE Codes
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.
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An Orange Book By Any Other Name …
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 Talks Tough On Complete Response Extensions
The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
US FDA Talking Tough On ANDAs, Says Extensions On Complete Responses Need Justification
But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.