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FDA sends Carestream Health an approval letter for its CareStream DirectView CR, a high-resolution computed radiography system for...[ Price : $8.95]
Federal Register Final rule: FDA reclassifies the full-field digital mammography system from Class 3 to Class 2 with a guidance do...[ Price : $8.95]
Federal Register Notice: FDA releases a special controls guidance on full-field digital mammography system.[ Price : $8.95]
MannKind says it will vigorously defend a suit charging that it fired a regulatory affairs senior manager in retaliation for his c...[ Price : $8.95]
Pozen says a Gastrointestinal Drugs Advisory Committee vote supports its Phase 3 trial design for PA 32540 for secondary preventio...[ Price : $8.95]
FDA issues a guidance on trial information for sponsors of cellular therapy for cardiac disease.[ Price : $8.95]
FDA approves a Bristol-Myers Squibb NDA for Kombiglyze XR (saxagliptin and metformin extended-release) for treating Type 2 diabete...[ Price : $8.95]
In its efforts to harmonize data standards for regulatory purposes, FDA principal deputy commissioner Joshua Sharfstein denies the...