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Manufacturers Life Sciences Today's Popular Updates

Manatt, Phelps & Phillips, LLP

Court Rules in Favor of Manufacturers in 340B Drug Shipment Case

On May 21, the U.S. Court of Appeals for the District of Columbia Circuit upheld the right of pharmaceutical manufacturers to place at least some restrictions on the shipment of 340B drugs to contract pharmacies of 340B...more

Gardner Law

[Ongoing Program] SESSION 3: Privacy Policy Pop Quiz – Are You Ready? - August 8th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 2: Do I Really Need A Privacy Officer, DPO or CISO? - July 18th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 1: 10 Things You Should Know About Privacy, Consent, and HIPAA - June 13th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McGuireWoods LLP

FDA Publishes New Guidance on Cybersecurity in Medical Devices

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In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more

Morgan Lewis

AI in Medical Devices and Healthcare: Opportunities, Challenges, and What Lies Ahead

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In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more

Allen Matkins

Life Sciences Real Estate Update -1.06.23 #1

Allen Matkins on

California’s lab and biotech industries provide 435,693 jobs that generate $376 billion in total economic output, according to a new report from Biocom California, an association representing life sciences companies and...more

McDermott Will & Emery

UK Medical Device Regulator Proposes a 12 Month Delay for UKCA Requirements and the New Medical Device Regulations

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On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

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The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

MoFo Life Sciences

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

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Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

Hogan Lovells

IoT in the EU: Lessons from COVID-19, and next steps for liability and regulation

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The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the...more

Goodwin

Novel DOJ Settlement For Sunshine Act Violations

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On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more

Benesch

3D Printing Quarterly Report - Q4 2019

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Rösler expands AM Solutions division to offer 3D printing services - AM Solutions, the Italian 3D printing subsidiary of the Rösler Group, a German company specializing in surface finishing solutions, will expand to offer a...more

Orrick - On the Chain

At Your Service: First-Ever On the Chain Survey Reflects a Steady Rise in Blockchain Awareness, Acceptance and Adoption

Orrick - On the Chain on

The results are in! Responses to Orrick’s first survey of the dedicated followers of On the Chain, our blockchain blog, revealed at least two things: (1) that blockchain technology is continuing to gain acceptance in and...more

Hogan Lovells

Harmonizing cybersecurity for medical devices: International collaboration moves forward

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On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more

Baker Donelson

FDA Issues Cybersecurity Alert to Health Care Providers and Device Manufacturers

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The U.S. Food and Drug Administration took the unprecedented step this week of issuing an alert to health care providers and device manufacturers about potentially serious security flaws that may allow hackers to remotely...more

Jones Day

Antitrust Alert: New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities

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Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar companies that relate to the...more

Benesch

3D Printing Quarterly Report - Q2 2018

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Global Advanced Metals and LPW Technology partner on 3D printing of tantalum devices - Global Advanced Metals (GAM), a maker of tantalum and niobium products, and LPW Technology, a metal powder for additives manufacturer,...more

Benesch

3D Printing Quarterly Report - Q1 2018

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African labs build 3D printers from e-waste - Two labs in African nations have built 3D printers out of e-waste. Staff at WoeLab in Togo, a community tech hub and inventor/entrepreneur network, built a 3D printer in 2013...more

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