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Daniel Orr

Omaha
As seen in: arXiv, Texas Monthly, JD Supra, WTIU-TV (Bloomington, IN), Earth Eats, Mother Earth Living, Data Science Central, Westlaw Today, Glasstire, Texas Highways and

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Articles

New FDA Draft Guidance Clarifies Three-Year Exclusivity for New Clinical Investigations

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By Daniel Orr, Eva Yin
| JD Supra
Key Takeaways The U.S. Food and Drug Administration (FDA) recently published new draft guidance to clarify the New Clinical Investigation Exclusivity, or 3-Year Exclusivity, for applicants or sponsors of a new drug application (NDA) or NDA supplement. The guidance is written in question-and-answer format. It clarifies what clinical investigations are eligible for the exclusivity and how applicants should request it from the FDA.
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New FDA Draft Guidance Clarifies Three-Year Exclusivity for New Clinical Investigations

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By Eva Yin, Daniel Orr, Wilson Sonsini Goodrich
| Westlaw Today Verified
The U.S. Food and Drug Administration (FDA) recently published new draft guidance to clarify the New Clinical Investigation Exclusivity, or 3-Year Exclusivity, for applicants or sponsors of a new drug application (NDA) or NDA supplement....
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Review: “Myth and Marble” at the Kimbell Art Museum, Fort Worth

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By Daniel Orr
| buff.ly
An installation view of “Myth and Marble: Ancient Roman Sculpture from the Torlonia Collection” at the Kimbell Art Museum. ©️ Fondazione Torlonia. Photo: Daniel Orr When he arrived in Rome in 1786, Johann Wolfgang von Goethe found himself moved to the core. Rome was far removed from his day-to-day political worries in Weimar, Germany. It served as a Mediterranean vacation that Goethe didn’t realize he needed, and put the poet-philosopher in touch with antiquity.
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