Citeline Podcasts

Drug Fix: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms

09 Aug 2024

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Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03). More On These Topics From The Pink Sheet ‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity: https://pink.citeline.com/PS155063/You-Shall-Not-Pass-Former-Surgeon-General-On-Why-US-Government-Should-Push-Trial-Diversity Gaps Found In Most Pharma Trial Diversity Policies: https://pink.citeline.com/PS155086/Gaps-Found-In-Most-Pharma-Trial-Diversity-Policies Zevra’s Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment: https://pink.citeline.com/PS155091/Zevras-Arimoclomol-Use-With-Standard-Of-Care-Complicates-US-FDA-Adcomm-Efficacy-Assessment Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel: https://pink.citeline.com/PS155100/Back-To-White-Oak-US-FDA-Adcomms-Go-Fully-InPerson-Starting-With-Antimicrobials-Panel

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3ª PARTE | 17 DIC 2025 | EL PARTIDAZO DE COPE

01 Jan 1970

El Partidazo de COPE

13:00H | 21 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

12:00H | 21 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

10:00H | 21 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

13:00H | 20 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

12:00H | 20 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

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Citeline Podcasts

Drug Fix: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms

This episode hasn't been transcribed yet

Other recent transcribed episodes

3ª PARTE | 17 DIC 2025 | EL PARTIDAZO DE COPE

13:00H | 21 DIC 2025 | Fin de Semana

12:00H | 21 DIC 2025 | Fin de Semana

10:00H | 21 DIC 2025 | Fin de Semana

13:00H | 20 DIC 2025 | Fin de Semana

12:00H | 20 DIC 2025 | Fin de Semana

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