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CDRH comes under fire after quietly revising its Classification Questionnaire (Form FDA 3429) based on a citizen petition that que...[ Price : $8.95]
Dara BioSciences files an Orphan Drug Application for KRN5500, a compound in development to treat a painful form of chronic chemot...[ Price : $8.95]
FDA approves a Mylan ANDA for tolterodine tartrate tablets (1mg and 2mg), a generic version of Pharmacia and Upjohns Detrol.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on the use of constituent material in biologic...[ Price : $8.95]
Federal Register Notice: FDAs Orthopedic and Rehabilitation will meet 4/5/13 to discuss the possible reclassification to Class 3 o...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on preclinical assessment of investigational cellular and gene therapy prod...[ Price : $8.95]
House Energy and Commerce Committee chair Fred Upton announces subcommittee chairs and vice chairs.[ Price : $8.95]
FDA clears a NeuroMetrix 510(k) for a disposable electrode that is used in conjunction with its SENSUS device, a transcutaneous el...