Archives: Industry Developments

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Upcoming Free Educational Opportunities for Life Sciences Clients

As the life sciences industry continues to undergo significant changes, Reed Smith is committed to offering high quality, free educational opportunities for its pharmaceutical, medical device, and biotechnology clients. We thus are pleased to shared two upcoming opportunities with you. First, because the new import tariffs proposed by the current administration could significantly affect life … Continue Reading

DOJ Granston Memorandum May Promote Dismissal of Unmeritorious FCA Qui Tam Lawsuits

Michael Granston, the Director of the Commercial Litigation Branch within the United States Department of Justice’s Fraud Section, recently issued an internal memorandum affirming his prior statements that the Department of Justice (DOJ) should consider seeking dismissal of meritless False Claims Act (FCA) suits brought by relators in qui tam cases. Under 31 U.S.C. § … Continue Reading

Florida Court is Latest to Vacate FCA Judgment

As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi discusses a recent case, in which the Middle District of Florida issued a blistering opinion vacating a $350 million judgment in a False Claims Act (FCA) case and granting the … Continue Reading

FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an … Continue Reading

Senate Bill Seeks to Provide “Floor” for Cybersecurity Operational Standards for Internet-Connected Devices Purchased by Federal Agencies

A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency. Should the legislation be enacted, the expectations it sets forth regarding the security of IoT devices could be interpreted by courts as the minimal floor for any … Continue Reading

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where … Continue Reading

FDA Withdraws “Compounding Animal Drugs from Bulk Drug Substances” Draft Guidance

The U.S. Food & Drug Administration (“FDA”) announced on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.” FDA confirmed that it does not intend to finalize the current draft. Rather, it will issue a new draft in early 2018 for public comment. For … Continue Reading

Upcoming Free CLE Webinar: “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”

The Reed Smith life sciences product liability and 3D printing teams will be hosting an upcoming CLE webinar “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8, 2017 at 12 p.m. ET. Reed Smith presenters Jim Beck and Matt Jacobson will be discussing 3D … Continue Reading

Revised International Enforcement Guidelines Prescribe Increasing Collaboration Between U.S., Foreign Competition Agencies to Investigate, Prosecute Antitrust Violations

Companies, including those in the pharmaceutical and medical device industries, with multinational operations should expect increasing collaboration between U.S. and foreign competition agencies to investigate and prosecute alleged antitrust violations.  In light of recent and ongoing investigations by U.S. and UK competition agencies into generic and sole-source drug pricing, the revised guidelines are expected to … Continue Reading

FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs).  According to FDA, the updated proposal is the result of ongoing engagement with industry stakeholders.   Under the proposal, the FDA generally stands by its position that a complementary risk-based … Continue Reading

Radiopharmacies Celebrate the New Year with Long-Awaited FDA Guidance

On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.”  The guidance addresses conditions under which the FDA does not intend to take action for violations of 505, 502(f)(1) and 501(a)(2)(B) of … Continue Reading

FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role

On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,”  which reconfirms its position on the importance of 3D printed medical devices.  The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., … Continue Reading

Reed Smith Launches Second Edition of 3D Printing White Paper

Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly:  3D Printing of Manufactured Goods: … Continue Reading

MDR Reporting Final Guidance

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”.  As with all such guidance documents, it is nonbinding:  “It does not establish any rights for any person and is not binding on FDA or the public.”  Nevertheless, for those interested in medical device reporting, the document is required reading as … Continue Reading

OIG Encourages CMS Claim Forms Which Will Allow For Better Tracking Of Implantable Medical Devices

On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for Medicare & Medicaid Services (CMS) on “Incorporating Medical Device-Specific Information on Claim Forms”.  This Early Alert urges CMS to update Medicare claims forms to include the “device identifier” (DI) portion … Continue Reading

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person … Continue Reading

Boosts in Ransomware Attacks Spark Multiple Government Agency Responses

Following a recent U.S. government interagency report indicating that, on average, there has been an alarming 300 percent spike in daily ransomware attacks since early 2016 as compared with 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released new Health Insurance Portability and Accountability Act (“HIPAA”) guidance on … Continue Reading

What Brexit Means for Data Protection

For global pharmaceutical and medical device companies handling personal data in the European Union (EU) or engaged in transatlantic data transfers, some of the many questions created by the Brexit vote include what its impact will be on the United Kingdom’s (UK) data protection laws. These questions also arise in the context of the EU’s … Continue Reading

New Edition of Singapore International Arbitration Centre Rules to Come into Effect Shortly

Pharmaceutical and medical device manufacturers are increasingly finding themselves resolving disputes through international arbitration. After London, Singapore is now arguably the second most important arbitration center in the world, meaning the Singapore International Arbitration Centre’s (SIAC) new arbitration rules, which were due to come into effect on June 1, 2016, but will now come into … Continue Reading

Upcoming Reed Smith Webinar on Recent Personal Jurisdiction Rulings, What Corporations Can Learn from Them

The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Personal Jurisdiction: What Bauman Does and Doesn’t Mean, the Other Side’s Response, and Why Corporations Should Care” on June 14, 2016 at 12 p.m. ET. Reed Smith presenters Jim Beck and Steve McConnell will be discussing how plaintiffs’ lawyers are … Continue Reading

FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices

The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug.  It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014.  FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading

Appeals Court Decision is Positive News for Health Companies Concerned About Cyberliability Coverage

In a ruling particularly meaningful to health care companies, who are responsible for patients’ protected, personally-identifiable information, the U.S. Court of Appeals recently upheld a lower court’s decision finding coverage under a healthcare company’s comprehensive general liability (CGL) policy.  When the health care company inadvertently made certain confidential medical records accessible to the public online … Continue Reading
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