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  • Eight Key Steps Toward EU-MDR Implementation

    13 November 2017

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FDA Unveils Plan for CDER Draft Guidance in 2018

19 January 2018

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Elemental Impurities Deadline Contributes to Spike in CRLs for Generic Drugmakers

19 January 2018

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Regulatory Recon: Government Shutdown Looms; First PARP Inhibitor Approved in Japan (19 January 2018)

19 January 2018

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FDA Warns 5 Drugmakers in China, Australia and Austria

18 January 2018

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Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

18 January 2018

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FDA Offers Recommendations on Highlights Section of Labeling

18 January 2018

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The Battle Over Neulasta Biosimilars in the US: What's Coming in 2018

18 January 2018

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European Regulatory Roundup: MHRA Rolls Out Online Portal to Streamline Medical Device Regulatory Services (18 January 2018)

18 January 2018

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Regulatory Recon: Kite Teams Up With Pfizer on Lymphoma Combo; Fed Up With Drugmakers, Hospitals Start Their Own (18 January 2018)

18 January 2018

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The Next Emflaza: Acer Therapeutics Looks to Take a Page Out of Marathon's Book

18 January 2018

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