• Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

    30 March 2015

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First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report

17 April 2015

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Regulatory Recon: Health Insurers Want Reforms to FDA's 510(k) Pathway (17 April 2015)

17 April 2015

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European Regulatory Roundup: Blood, Plasma and Human Tissues in Europe (16 April 2015)

16 April 2015

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Regulatory Professionals Need Better Understanding of Medical Device Validation

16 April 2015

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Inadequate Medical Device Validation a Common Problem; RAPS Publishes 'How-to' Resource

16 April 2015

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Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History

16 April 2015

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Tougher FDA Approval Process for Opioids Sought by Congress

16 April 2015

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EMA Releases Draft Guides to Reduce and Report Medication Errors

16 April 2015

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Zarxio, First Biosimilar Approved in the US, Added to FDA's New 'Purple Book'

16 April 2015

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Regulatory Recon: FDA Approves Amgen's Heart Failure Drug Corlanor (16 April 2015)

16 April 2015

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