• eCTD: Journey Through the Decade

    21 July 2016

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FDA Sends Untitled Letter to Danish Drugmaker Over GMP Issues

25 July 2016

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UDI Form and Content: FDA Offers Draft Guidance

25 July 2016

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FDA Continues Steady Reduction of Generic Drug Application Backlog

25 July 2016

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Regulatory Recon: FDA Panel Split Over Alere Diabetes Diagnostic; EMA Recommends Suspending Drugs Over Data Integrity Issues at Semler (25 July 2016)

25 July 2016

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Regulatory Recon: Theranos Brings in New Regulatory, Compliance Execs; Valeant Gets CRL for Glaucoma Drug Over GMP Issues at Manufacturer (22 July 2016)

22 July 2016

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EMA to Revise Phase I Trial Guidance, Draft Expected in Late 2016

22 July 2016

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European Regulatory Roundup: Novartis Faces MHRA Criticism on Trial Data Access (21 July 2016)

21 July 2016

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Regulatory Recon: Novartis CEO Predicts US Drug Pricing Overhaul; Chinese Scientists to Launch First Human CRISPR Trial (21 July 2016)

21 July 2016

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RAPS and the Regulatory Profession: Elevating Standards Through Education and Certification

21 July 2016

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FDA Warns GSK’s UK Site for Contamination in API Manufacturing

20 July 2016

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