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FDA clears a Fenwal 510(k) for its Alyx component collection system that is designed with new wireless data export capabilities.[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for The Medicines Companys Angiomax for the purpose of patent...[ Price : $8.95]
Federal Register Notice: FDA releases a small entity compliance guide on CGMPs in manufacturing, packaging, labeling or holding op...[ Price : $8.95]
FDA approves a Neuralstem, Inc. IND to begin a Phase 1a safety trial of NSI-189 in major depression.[ Price : $8.95]
The investigative journalism Web site Fairwarning criticizes FDA and Pfizer for not initially testing Chantix on patients with men...[ Price : $8.95]
FDA clears an Accuray Inc. 510(k) for its Lung Optimized Treatment, a new component for the firm's CyberKnife VSI System for perfo...[ Price : $8.95]
Orion Corp. considers a patent infringement suit against Mylan after being told the company has submitted an ANDA for a generic co...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on the co-development of two or more unmarketed investigational drugs for u...