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Clinical Pharmacology

Communication

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NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

Putting Patients First Blog

SEPTEMBER 26, 2024

This includes being aware of historical injustices that may have contributed to mistrust in the medical system and understanding the unique needs and concerns of different communities. Effective communication with diverse populations is essential for ensuring that all individuals can participate in clinical trials. and Zhang, L.

Communication

Communication Clinical Pharmacology Documentation Drug Development

FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

The Guidance provides a listing of domains for such assessment as pertains to general concerns ( e.g. , quality of life, physical health) and neurodevelopmental concerns ( e.g. , sensory, motor, cognition, communication). The Guidance is written carefully to communicate that these determinations are all very case-specific.

Clinical Pharmacology

Clinical Pharmacology Communication Drug Development

Pharmacist Digest

NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development

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