Titan Pharmaceuticals Inc (TTNP): Does anyone know how post-marketing stud...

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Titan Pharmaceuticals Inc (TTNP)

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Thursday, 02/11/2016 6:53:27 PM

Thursday, February 11, 2016 6:53:27 PM

Does anyone know how post-marketing study requirements are handled by the FDA. Assuming a Phase IV will be required to determine long-term safety, does the FDA discuss that with the sponsor pre-approval? Or does it issue an "approvable" letter with a Phase IV condition and then approve once the sponsor agrees to the marketing study?

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Recent TTNP News

Form 8-K - Current report • Edgar (US Regulatory) • 01/25/2024 09:33:11 PM
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Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 10/24/2023 09:26:34 PM
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