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Public Citizen calls on FDA to immediately reinspect all compounding pharmacies that received Warning Letters in the past to ensur...[ Price : $8.95]
CBER issues a draft guidance with recommendations for information needed to support clinical trials for investigational cell, tiss...[ Price : $8.95]
FDAs Anti-Infective Drugs Advisory Committee unanimously votes to support efficacy findings with Janssen Research & Developments b...[ Price : $8.95]
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...