Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Partner

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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What is “Healthy?” Are Fats In?

Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

In a recent press release, the U.S. Patent and Trademark Office (USPTO) announced that, starting on April 18, 2023, the Office would begin issuing electronic patent grants (eGrants) to patent recipients. This process delivers the official copy of patent grants in an electronic format, instead of the previous paper version. The Office will still provide a bound paper version as a ceremonial copy throughout a limited transition period for free, and then for a nominal fee thereafter. In this article, MoFo’s Patent team explores the important implications of this change, particularly how it impacts the timing of filing continuing applications.Read the <a href="https://www.mofo.com/resources/insights/230412-uspto-to-launch-new-patent-issue-procedure" target="_blank">full client alert</a>.

USPTO to Launch New Patent Issue Procedure on April 18: What You Need to Know

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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USPTO to Launch New Patent Issue Procedure on April 18: What You Need to Know

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In a recent press release, the U.S. Patent and Trademark Office (USPTO) announced that, starting on April 18, 2023, the Office would begin issuing electronic patent grants (eGrants) to patent recipients. 

On April 3, 2023, the U.S. Plant Variety Protection Office (PVPO) held a preparatory session for the International Union for the Protection of New Varieties of Plants (UPOV) Technical Working Party for Vegetables (TWV) and Technical Working Party for Agricultural Crops (TWA) virtual meetings in May. This session was to provide an opportunity for feedback and comments on the UPOV Test Guidelines and the PVPO Exhibit C forms.In regard to the UPOV Test Guidelines, the PVPO will be submitting comments received on the PVPO Hemp (Cannabis) form to the UPOV Technical Working Party. As of April 3, 2023, there were no plans for the PVPO to submit comments on any of the other crops that will be discussed in the May meetings.In regard to the PVPO Exhibit C forms, the PVPO is currently in the process of aligning Exhibit C forms for all crops with the UPOV Test Guidelines. The Exhibit C forms are being updated on an as-requested basis, which means that only those forms that have been updated are currently available on the PVPO website. You can contact the Office (via <a href="mailto:AMS.PVPOForms@usda.gov">AMS.PVPOForms@usda.gov</a>) to request specific forms, ask about the status of specific forms, or ask other form-related questions. Over time, all of the forms will be updated.The PVPO stated that some older characteristics, which have been important for variety searches in the past, will be retained on the updated Exhibit C forms. In addition, the PVPO will retain quantitative traits in the updated Exhibit C forms.There is a new “area of adaptation” section on the updated Exhibit C forms, which will include options for both field-grown varieties and greenhouse-grown varieties. Over time, the PVPO will be updating its dashboard to display varieties by their area of adaptation, to facilitate variety searching. This dashboard will eventually replace the current certificate management system.If you have any comments on Exhibit C forms, they can be submitted to the Plant Variety Protection Office via email (<a href="mailto:pvpomail@usda.gov">pvpomail@usda.gov</a>), and the Examiner who handles the crops will review. MoFo’s <a href="https://www.mofo.com/capabilities/plant-intellectual-property" target="_blank">Plant IP</a> team will continue to monitor developments related to the PVPO and will post future updates on our blog.

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Sr Patent Agent

Dr. Claire Bendix’s work focuses on patent preparation, patent prosecution, and matters pertaining to plant variety protection both in the United States and abroad. She also has experience in conducti

Claire L. Bendix Ph.D.

Claire Bendix

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Patent Agent

Dr. Deborah Pohlmann focuses on patent preparation and prosecution, specializing in biology.
Prior to joining the firm, Deborah earned her Ph.D. in biology from the Massachusetts Institute of Technolo

Deborah A. Pohlmann Ph.D.

Deborah Pohlmann

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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U.S. Plant Variety Protection Office Invited Comments on UPOV Test Guidelines and Is Aligning Exhibit C Forms with UPOV

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On April 3, 2023, the U.S. Plant Variety Protection Office (PVPO) held a preparatory session for the International Union for the Protection of New Varieties of Plants (UPOV) Technical Working Party for Vegetables (TWV) and Technical Working Party for Agricultural Crops (TWA) virtual meetings in May. This session was to provide an opportunity for feedback and comments on the UPOV Test Guidelines and the PVPO Exhibit C forms.

U.S. Plant Variety Protection Office Invited Comments on UPOV Test Guidelines and Is Aligning Exhibit C Forms with UPOV

A recent putative class action case against luxury brand Christian Dior sheds light on the health care exemption in the Illinois Biometric Privacy Act (BIPA). In Delma Warmack-Stillwell v. Christian Dior Inc., the plaintiff alleged Dior’s virtual try-on feature for sunglasses violated BIPA’s requirements to (1) provide notice and obtain informed consent before collecting an individual’s biometric data; (2) have a written retention and deletion policy for biometric data; and (3) not sell, lease, trade, or otherwise profit from an individual’s biometric data. [1] The Northern District of Illinois dismissed the case, finding that the feature fell within BIPA’s health care exemption. [2]Read our full <a href="https://www.mofo.com/resources/insights/230403-applying-bipas-health-care-exemption" target="_blank">client alert.</a>[1] Warmack v. Christian Dior, Inc., No. 1:22-cv-04633, Dkt. No. 29 at 3 (Feb. 10, 2023).[2] Id. at 12.

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Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector.

Melissa M. Crespo

Melissa Crespo

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Associate

Morgan Mitruka is an associate in Morrison Foerster’s Litigation Department, based in the San Francisco office.

Morgan O'Neill Mitruka

Morgan Mitruka

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Applying BIPA’s Health Care Exemption to Virtual Try-On Technologies in Light of Dior Dismissal

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A recent putative class action case against luxury brand Christian Dior sheds light on the health care exemption in the Illinois Biometric Privacy Act (BIPA).

Applying BIPA’s Health Care Exemption to Virtual Try-On Technologies in Light of Dior Dismissal

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) <a href="https://www.fda.gov/media/155038/download" target="_blank">Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a> (the “Enforcement Policy Transition Guidance”) and 2) <a href="https://www.fda.gov/media/155039/download" target="_blank">Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)</a> (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.Enforcement Policy Transition GuidanceThe 180-day transition period under the Enforcement Policy Transition Guidance will start on the “implementation date,” which will be May 11, 2023, unless the PHE declaration is renewed another time contrary to the <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">Administration’s current plan</a>. The Enforcement Policy Transition Guidance applies to devices that fall under 15 FDA COVID-19 enforcement policies, where FDA has indicated that it does not intend to object to certain modifications or distribution of certain devices in the following categories:<ol><li>remote digital pathology devices;</li><li>imaging systems;</li><li>non-invasive fetal and maternal monitoring devices;</li><li>telethermographic systems;</li><li>digital health devices for treating psychiatric disorders;</li><li>extracorporeal membrane oxygenation and cardiopulmonary bypass devices;</li><li>remote ophthalmic assessment and monitoring devices;</li><li>infusion pumps and accessories;</li><li>face shields, surgical masks, and respirators;</li><li>gowns, other apparel, and gloves;</li><li>sterilizers, disinfectant devices, and air purifiers;</li><li>ventilators and accessories and other respiratory devices;</li><li>FDA-cleared molecular influenza and RSV tests;</li><li>coagulation systems; and</li><li>viral transport media.</li></ol>These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023.The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after the implementation date—expected to be from May 11 to August 8, 2023); Phase 2 (the second 90 days after the implementation date—expected to be from August 9 to November 6, 2023); and Phase 3 (180 days after the implementation date—expected to begin on November 7, 2023). In the Enforcement Policy Transition Guidance, FDA provides phase‑by‑phase compliance guidance for manufacturers of a device that falls under any of the FDA COVID-19 enforcement policies mentioned above. It is important to note that some of the guidance applies to manufacturers regardless of whether they intend to continue distribution of the device after a certain phase. For example, manufacturers should send a notification of intent to FDA regardless of whether they intend to continue distribution of their device after Phase 2.EUA Transition GuidanceThe 180-day transition period under the EUA Transition Guidance, on the other hand, will start when the corresponding EUA declaration terminates (the “EUA termination date”). The EUA Transition Guidance applies to devices that are authorized under any of the EUA declarations related to COVID-19 such as the <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">EUA declaration for COVID-19 in vitro diagnostics</a> (the “EUA devices”). As FDA explains in the guidance, an EUA declaration is not dependent on the PHE declaration, which means that the 180-day transition period for the EUA devices may start well after the PHE declaration expires, that is, possibly well after May 11, 2023.The EUA Transition Guidance requests manufacturers of the EUA devices that FDA deems to be “reusable life-supporting or life-sustaining” to submit a letter of intent to FDA as soon as possible, regardless of their intent to continue distribution of the device after the EUA termination date. Note that this request is effective as of March 27, 2023, and manufacturers should not wait until the transition period or the EUA termination date to submit the intent letter. Section A of the guidance provides the details including the product codes relevant to this request and the information to include in the letter.The EUA Transition Guidance also provides recommendations and policies for manufacturers seeking a full marketing authorization for a device related to any of their EUA devices. The guidance indicates that FDA does not intend to object to continued distribution of the EUA device after the EUA termination date, if (i) the manufacturer submits a marketing submission for a candidate device that is the same as, derivative of, or next generation of the EUA device, (ii) FDA formally accepts the marketing submission before the EUA termination date, and (iii) FDA has not taken a final action on the marketing submission. Since FDA’s formal acceptance of the marketing submission could be delayed due to various reasons, including administrative incompleteness of the submission, manufacturers are advised to submit well before the EUA termination date.FlexibilitiesNotably, both guidance documents indicate FDA’s willingness to be flexible in certain areas. For example, the guidance documents indicate that real-world data from the actual use of the device during the COVID-19 pandemic may be included in the marketing submission. Both guidance documents also recommend manufacturers to engage with FDA early in the transition period to discuss extenuating circumstances such as an ongoing clinical study that makes it difficult to meet certain deadlines provided in the guidance. Further, both guidance documents acknowledge that there may be unique quality system compliance considerations for certain manufacturers and suggest requesting an exemption or variance from a device quality system requirement within the first 90 days of each transition period.Finalization of these guidances does not necessarily mean that the COVID-19 EUA declarations will be terminated soon or that FDA will soon cease accepting and reviewing new EUA requests. At the same time, however, it certainly gets us closer to such transitions. This is an important development, and manufacturers who have distributed devices under an EUA or under one of these enforcement discretion policies during the pandemic should seek the advice of counsel to ensure compliance with the transition.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Issues Final Transition Guidances for COVID-19 Devices

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This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations:

FDA Issues Final Transition Guidances for COVID-19 Devices

On Thursday, March 23, 2023, the Food and Drug Administration (FDA) <a href="https://www.federalregister.gov/documents/2023/03/24/2023-06066/framework-for-the-use-of-digital-health-technologies-in-drug-and-biological-product-development" target="_blank">announced</a> the publication of the “<a href="https://www.fda.gov/media/166396/download" target="_blank">Framework for the Use of Digital Health Technologies in Drug and Biological Product Development</a>” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The publication of this digital health technology (DHT) framework fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act reauthorization (PDUFA VII).What Are DHTs?In the context of the Framework, DHTs are “systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses.” This includes technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (i.e., drugs, devices and biologics). DHTs can be in the form of hardware (e.g., sensors for recording of physiological and/or behavioral data), software (e.g., mobile phone, smart watch), or a combination of both hardware and software (e.g., continuous glucose monitoring device with sensor and mobile application). DHTs may be used to support more efficient drug development and uses include increasing decentralization of trial-related activities (e.g., promoting increased trial diversity and retention of study participants), facilitating direct collection of information from patients, and allowing for development of novel endpoints that can help paint a more detailed picture of how participants feel and function in their daily lives.The Framework describes the multifaceted approach FDA intends to use to address how DHTs can be used to support drug development and regulatory decision-making, including workshops and demonstration projects, stakeholder engagement, establishment of internal processes to support evaluation of DHTs for use in drug development, and publication of guidance documents. The Framework itself is “not a guidance document and does not propose or establish policies.”Some of the significant issues addressed in the framework include:DHT Steering Committee – FDA established the DHT Steering Committee to develop internal programs to build review capacity and expertise and to ensure consistent review policies for the use of DHTs in drug development. The Committee has overseen the design of the Framework, and consists of senior staff from CDER, CBER, and the Center for Devices and Radiological Health, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs. Committee activities will include:<ul><li>Gathering information on the present state of DHTs</li><li>Making policy recommendations on the use and evaluation of DHT-based measurements in drug development</li><li>Overseeing and coordinating DHT-related drug development working groups</li><li>Engaging with external stakeholders on DHT-related issues in drug development</li></ul>Technical Expertise and Training – FDA will “build on its technical expertise and develop training within the human drugs and biological products programs to enhance internal knowledge regarding the use of DHTs in drug development.” Areas of focus include: verification and validation, use of a participant’s own DHT or general-purpose computing platform, upgrades and updates of DHTs in drug development, artificial intelligence and machine learning, and technical consultation of experts and staff training.Consistency of Evaluations Across Review Divisions – “A single DHT measurement may be used for studies of different diseases and different drugs.” Review divisions and centers in the FDA should have consistent approaches to the review and evaluation of submissions that contain DHT-related data, and the Steering Committee is tasked with facilitating consistent approaches.Statistical Considerations in the Analysis of DHT-Derived Data – The use of DHT-derived endpoints presents “unique statistical considerations” for FDA related to data quality, technical data specifications, provenance, techniques, and algorithms used for processing, summarizing, and analyzing DHT data, and treatment of missing data during its reviews. Existing and novel statistical methods of validation of DHT-derived data must be assessed, and FDA states it will “consider developing technical data specifications to facilitate submission of readily analyzable DHT-derived data supporting drug development.” IT Capabilities – FDA anticipates “new challenges” with the “ability to receive and analyze large DHT-generated datasets to support a regulatory decision.” FDA will enhance its IT capabilities to support the review of such, including development of internal systems to monitor trends in submissions containing DHT-related data and establishment of a secure cloud technology to enhance infrastructure and analytics. After establishing the cloud, FDA will pilot a secure, cloud-based mechanism to support submission and review of DHT-generated datasets.FDA Meetings with Sponsors – FDA engagement with sponsors regarding the use of DHTs may occur at different stages of drug development, including pre-submission meetings, pre-IND meetings, IND and NDA review meetings, and other meetings and communications.Drug Development Tool Qualification Program – “FDA has qualification programs that are intended to support the development of tools for use in assessing medical products and that provide another avenue for sponsors and other stakeholders to engage with the Agency.” DHT developers may choose to pursue qualification of DHTs as drug development tools for a specific use, and a qualified DHT may be relied upon in multiple clinical investigations to support premarket drug submissions where the context of use is the same without having to repeat studies to support qualification.Guidance – To facilitate the appropriate use of DHTs in drug development, FDA has published various draft guidances, including the following:<ul><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations" target="_blank">Digital Health Technologies for Remote Data Acquisition in Clinical Investigations</a> (Dec. 2021)</li><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions" target="_blank">Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers</a> (Mar. 2023)</li></ul>FDA plans to develop additional guidance in identified areas of need informed by stakeholder engagement and plans to publish the following draft guidance in 2023:<ul><li>Decentralized Clinical Trials for Drugs, Biological Products, and Devices (planned for 2023)</li><li>Regulatory Considerations for Prescription Drug Use-Related Software (planned for publication by end of 2023)</li></ul>Public Meetings – By Q2 2023 FDA will convene the first of a series of five public meetings or workshops with key stakeholders to gather input on issues related to the use of DHTs in regulatory decision-making for drug and biological product development. The first meeting is March 28–29, 2023 on <a href="https://duke.is/pzkwx" target="_blank">Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review</a>. Other meetings will be designed to address the following topics:<ul><li>Identifying approaches to DHT verification and validation</li><li>Understanding DHT data processing and analysis to inform the need for novel analytical techniques</li><li>Addressing the regulatory acceptance of safety monitoring tools that utilize AI/ML-based algorithms for pharmacovigilance purposes</li><li>Understanding emerging issues</li></ul>Demonstration Projects – “FDA will identify at least 3 issue-focused demonstration projects to inform methodologies for efficient DHT evaluation in drug development.” These projects may involve engagement with researchers, patient groups, and other stakeholders and will cover key issues to inform regulatory policy development and provide regulatory advice.External Organizations – FDA has participated in several forums addressing the use of DHTs in drug development and will continue to engage with external organizations to facilitate meeting the objectives discussed above.<a href="https://www.regulations.gov/docket/FDA-2022-N-3319" target="_blank">Comments on the Framework</a> must be submitted by May 23, 2023. MoFo is continuously monitoring these developments. Please reach out to MoFo’s FDA + Healthcare Regulatory and Compliance practice for a more detailed analysis and discussion of the implications of these developments.

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FDA Publishes Digital Health Technology Framework

FDA Publishes Digital Health Technology Framework