• Biological Products and Biosimilars: Global Naming Debate

    27 June 2017

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FDA Clears First MRI Meant for Use in NICUs

20 July 2017

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CDRH Clarifies Process for Consensus Standard Recognition Requests

20 July 2017

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Ten Secrets to Regulatory Success

20 July 2017

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European Regulatory Roundup: EU Watchdog Probes Whether Pre-Submission Meetings Enable Industry to Influence EMA (20 July 2017)

20 July 2017

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Regulatory Recon: NICE Gives Final OKs to Amgen's Kyprolis, Teva's Cinqaero; Ablynx, Sanofi Sign Immunology Deal Worth Up to $2.8B (20 July 2017)

20 July 2017

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FDA Warns Phototherapy Device Maker for Quality System Issues

19 July 2017

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Careers in Regulatory Advertising and Promotion

19 July 2017

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FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings

19 July 2017

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Regulatory Recon: Vertex Three Drug Cystic Fibrosis Combos Beat Expectations; FDA Approves Gilead's Vosevi for 2nd Line HCV Treatment (19 July 2017)

19 July 2017

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Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017

18 July 2017

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