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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...

Race, Ethnicity Data Collection Guidance

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FDA issues a guidance on collecting race and ethnicity data for clinical trial submissions.

Spectranetics PMA for Drug-Coated Angioplasty Balloon

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Spectranetics Corp. files a PMA for the Stellarex drug-coated angioplasty balloon, for use in restoring and maintaining blood flow...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Beijing Taiyang Pharmaceutical Industry, Option Care Enterprises, and Wellcare R...

FDA Priority Review for Novartis Breast Cancer Drug

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FDA accepts for priority review a Novartis NDA for LEE011 (ribociclib) as a first-line treatment of postmenopausal women with horm...

Beijing Taiyang Refused, Limited FDA Inspection

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FDA warns Chinas Beijing Taiyang Pharmaceutical Co. about limiting and refusing an agency inspection and CGMP deviations.

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...