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Federal Register Notice: FDA releases a guidance on labeling recommendations for blood lancets that the devices be used for only a...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on ANDAs: Impurities in Drug Products.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance, Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval.[ Price : $8.95]
The Medicines Company reaches agreement with FDA under a Special Protocol Assessment on Phase 3 clinical trials for oritavancin in...[ Price : $8.95]
FDA reviewers question the relevance of clinical trials submitted to support labeling changes for Avodart and Proscar relating the...[ Price : $8.95]
Gen-Probe files a PMA for its Aptima HPV (human papillomavirus) assay, a new molecular test that detects high-risk HPV infections ...[ Price : $8.95]
FDA extends by three months its review of an EMD Serono NDA for cladribine tablets as a therapy for relapsing forms of multiple sc...[ Price : $8.95]
FDA says it generally agrees with an HHS Inspector General recommendation that it do a better job of ensuring completeness and acc...