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Michelle Ofori

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Authored Content

January 26, 2024 | Insights & Analysis > Regulatory Strategy and FDA Policy

Status of US Prescription Drug Importation Pathways
Recent FDA authorization of Florida’s Section 804 Importation Program has prompted increased focus on importation pathways.
November 30, 2023 | Insights & Analysis > Regulatory Strategy and FDA Policy

Complete Response Letters: Implications for Product Access
Receiving a complete response letter is not a rejection, but it introduces important business questions for product launch planning.