1. Pink Sheet

How To Conduct A Multi-Company Trial For Rare Pediatric Diseases

 
• By Brenda Sandburg

US FDA draft guidance suggests efficacy endpoints for testing multiple drug products in the same clinical trials; advances an FDA-EMA joint proposal promoting innovative approaches for development of Gaucher disease medicines.

children's soft toy teddy bear with pills takes the temperature of a mercury glass thermometer. child' disease.

The US FDA is casting a spotlight on a new approach to the development of drugs for rare pediatric diseases in which companies would test multiple product candidates in the same clinical trial.

FDA and the European Medicines Agency suggested this course of action in a joint proposal to promote the use of...

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