Eyenovia, Inc.
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Latest From Eyenovia, Inc.
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Contrast Agents Regain ‘Drug’ Status, But Ophthalmic Products Still Subject To Genus Decision
Legislative rider effectively reverses Genus court ruling, and now US FDA must treat contrast agents, radioactive drugs and OTC monograph drugs as drugs. However, the agency will have to assess case-by-case whether certain ophthalmic products meet the definition of ‘drug’ or ‘device.’
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Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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