EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
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FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
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EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
New Draft Guideline issued; consultation end date: July 2019
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EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
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FDA Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
New FDA Guidance for Industry
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