2018, Clinical Pharmacology and Drug Development

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2018

Clinical Pharmacology

Drug Development

At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog: Biosimilars

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

Clinical Pharmacology

Clinical Pharmacology Drug Development

NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

Putting Patients First Blog

SEPTEMBER 26, 2024

Further discussion on the unique aspects of rare disease drug development, the associated challenges, and when waivers may be warranted would greatly benefit all stakeholders, including sponsors, patient organizations, clinical researchers, and regulators. Clinical Pharmacology & Therapeutics , 97(3) , 263–273.

Communication

Communication Clinical Pharmacology Documentation Drug Development

Pharmacist Digest

At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

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