Search Results for Gaucher

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More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could speed the development of treatments for rare pediatric disease drugs.

Categories: News, US, EMA, FDA, Clinical, Drugs

Tags: rare pediatric disease, Gaucher, FDA draft guidance

EMA and FDA Look to Facilitate Development of Gaucher Disease Treatments By Zachary Brennan - Published 03 July 2017

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Monday released a new strategy document to aid in the development of new treatments for Gaucher disease, a rare lysosomal storage disorder.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EMA and FDA, Gaucher disease, rare pediatric disease

EMA, FDA Team Up to Propose Guideline on Pediatric Gaucher Disease By Alexander Gaffney, RAC - Published 15 May 2014

US and EU regulators have come together to release an unusual joint proposal that they say will help speed up the development of new treatments affecting pediatric patients with Gaucher disease.

Categories: Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: EMA, EU, Gaucher Disease, Gaucher's Disease, Guideline, Clinical Trials, Pediatric, Paediatric