Search Results for Natural History Studies

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Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies By Michael Mezher - Published 06 October 2017

The US Food and Drug Administration (FDA) on Friday awarded $32 million in research grants to fund 15 clinical studies and six natural history studies for rare diseases.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: Natural History Studies, Rare Diseases, Orphan Drugs, Grants

Industry Seeks More Specifics on FDA's Flexibility With Orphan Drug Guidance By Michael Mezher - Published 04 November 2015

Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its "regulatory flexibility" with orphan drug reviews.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Orphan products, Preclinical, Regulatory strategy

Tags: Orphan drugs, Natural history studies, PhRMA, BIO, NORD