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Researchers Urge Better FDA Monitoring of Post-approval Studies 09/22/2017

FDA Accelerated OK for Merck’s Keytruda in Gastric Cancer 09/22/2017

FDA Approves MRI-friendly Labeling for Abbott ICD and Leads 09/22/2017

FDA ‘Complete Response’ on Janssen Arthritis BLA 09/22/2017

Draft Guide for Biosimilar Analytical Similarity Evaluations 09/22/2017

Aegerion Pharma Pleading Guilty to Violating REMS 09/22/2017

5th Circuit Backs Solvay False Claims Case Dismissal 09/21/2017

Analytical Similarity Statistical Guidance Out 09/21/2017

Safety Alert Issued on Intercept’s Ocaliva 09/21/2017

FDA Clears Brainlab Radiosurgery Planning Software 09/21/2017

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