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Celgene, IBM Watson Partner on New Pharmacovigilance Program

[ Price : $8.95]

Celgene and IBM Watson Health collaborate to co-develop IBM Watson for Patient Safety, a new program that aims to enhance pharmaco...

FDA Workshop Planned for Generic Drug Research

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FDA says it will be holding a public workshop 5/3/2017 to obtain input from industry and other interested stakeholders on the iden...

Lap-Band Post Approval Study Completed

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Apollo Endosurgery says it has completed a post-approval study of its Lap-Band AP Adjustable Gastric Band called HERO (Helping Eva...

Sterile Drug Deficiencies at Option Care (Walgreens)

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FDAs Dallas District Office warns Option Care Enterprises (formerly Walgreens Home Care) about aseptic processing operation violat...

Comments Sought on Patent Term Revision Petition Extension

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Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection on Patent Term R...

Comments Sought on IRB Recordkeeping Requirements Extension

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Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend the recordkeeping requirements for institu...

FDA Extends Comment Period on MDUFA Reauthorization

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Federal Register Notice: FDA extends the comment period for the Medical Device User Fee Amendments reauthorization draft recommend...

Pfizer Scraps Cholesterol Drug on Disappointing Study Results

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Pfizer says it will discontinue its global clinical development program for bococizumab, an investigational proprotein convertase ...

Califf: Base Clinical Trials on Data Sources

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FDA commissioner Robert Califf says that data sharing will be the next big scientific revolution.

Large Molecule Drug Trials Take Longer: Analysis

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KMR Group says its analysis of clinical trial times shows that trials for large molecule drugs take longer than those for small mo...