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A New England Journal of Medicine editorial and commentary call for prompt congressional action to implement the Institute of Medi...[ Price : $8.95]
CDRH director of regulatory affairs Larry Spears says the agency doesnt have enough resources to regulate reprocessing of single-u...[ Price : $8.95]
FDA deputy commissioner Scott Gottlieb says more money will be allocated to drug safety in coming budgets.[ Price : $8.95]
CDER explains its current thinking on how to investigate out-of-specification test results in a new final guidance.[ Price : $8.95]
GlaxoSmithKline submits a supplemental NDA for expanded labeling on its Advair Diskus to reflect data showing a reduction in the r...[ Price : $8.95]
Roche and Trimeris delay an amended supplemental NDA for a needle-free administration of HIV therapy Fuzeon after FDA requests add...[ Price : $8.95]
An FDA-sponsored public meeting on nanotechnology, draws conflicting testimony on the need for new legal/regulatory authorities.[ Price : $8.95]
DeCode Genetics suspends a Phase 3 clinical trial involving its heart attack prevention drug in order to address an unexpected for...