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Electronically Stored Information Food and Drug Administration (FDA)

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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

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

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The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Hanzo

Neulasta FDA Advertising Compliance: An Illustration of Why Companies Need an Interactive Website Archive

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If a picture is worth a thousand words, what’s a video worth? Pharmaceutical companies invest heavily in online advertisements and product websites to explain their prescription medications’ uses, benefits, and risks. The...more

Hanzo

Complying With the FDA’s Advertising Regulations: Why You Need an Interactive Website Archive

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Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more

Faegre Drinker Biddle & Reath LLP

FDA Relaxes Modification Restrictions for Non-Invasive Remote Monitoring Devices During COVID-19 Public Health Emergency

On March 20, 2020, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued a new guidance document for industry and FDA staff, attempting to “help expand the availability and capability...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

BakerHostetler

FDA Proposes Electronic Distribution of Prescribing Information

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Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...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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