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BRIEF-U.S. FDA Proposes Drug Development Guidance For Rare Pediatric Diseases
December 6, 2017 / 6:24 PM / 9 days ago

BRIEF-U.S. FDA Proposes Drug Development Guidance For Rare Pediatric Diseases

Dec 6 (Reuters) - U.S. Food and Drug Administration:

* U.S. FOOD AND DRUG ADMINISTRATION RECOMMENDS NEW, “MORE EFFICIENT” APPROACH TO DRUG DEVELOPMENT FOR RARE PEDIATRIC DISEASES

* FDA SAYS ISSUED A DRAFT GUIDANCE CALLED “PEDIATRIC RARE DISEASES: COLLABORATIVE APPROACH FOR DRUG DEVELOPMENT USING GAUCHER DISEASE AS MODEL”

* FDA SAYS NEW DRAFT GUIDANCE DESCRIBES A POSSIBLE NEW APPROACH FOR COS TO COLLABORATE AND TEST MULTIPLE DRUG PRODUCTS IN THE SAME CLINICAL TRIALS

* FDA - NEW DRAFT GUIDANCE ALSO DISCUSSES USAGE OF SINGLE CONTROL GROUP AS BASIS FOR COMPARING SAFETY, EFFECTIVENESS OF MORE THAN ONE INVESTIGATIONAL DRUG Source text: (bit.ly/2ACm9fI)

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