An Orange Book By Any Other Name …
Executive Summary
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.
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Agency is setting up an internal working group to assess whether certain patent information should be included or removed from the Orange Book. PhRMA, AAM and others address therapeutic equivalence ratings and listing of device-related and REMS-related patents.
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Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.