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Steven Grossman writes in an FDA Matters column that it would be good to start to scale back CDER reliance on user fees by increas...[ Price : $8.95]
The Medial Technology and Practice Patterns Institute says that FDA should order changes to Epogen labeling to specify a safer tar...[ Price : $8.95]
Morgan, Lewis attorneys suggest ways in which drug and device companies can best communicate off-label information to healthcare p...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on end-of-Phase 2A meetings for investigational new drug sponsors.