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eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

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ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

Cozen O'Connor

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

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The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Polsinelli

FDA Releases Final Cybersecurity Guidance for Medical Devices

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Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

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