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Three Things to Know about FDA’s Newest Draft Guidance on Cell & Gene Therapies

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On September 23, 2025, the FDA published three new draft guidances that give insight into a regulatory framework for cell and...

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We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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On September 23, 2025, the FDA published three new draft guidances that give insight into a regulatory framework for cell and gene therapies (CGTs) that is now coming into focus. By releasing these guidances together, FDA is offering a blueprint for the future of CGT regulation.Read the <a href="https://lifesciences.mofo.com/topics/three-things-to-know-about-fda-s-newest-draft-guidance-on-cell-gene-therapies" target="_blank">full blog post</a>.

Three Things to Know about FDA’s Newest Draft Guidance on Cell & Gene Therapies

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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.As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Partner

Karen Potter, Ph.D., J.D., is a nationally recognized patent attorney and leader of Morrison Foerster’s Cell and Gene Therapy Patent practice in San Diego, California. With over 20 years of experience in life sciences intellectual property law, Karen specializes in patent strategy, prosecution, and portfolio management for biotechnology and pharmaceutical companies worldwide.Karen’s technical background in cellular and molecular biology and immunology uniquely positions her as a trusted advisor for innovators in:<ul><li>Cell and gene therapies (including T cell, Natural Killer cell, stem cell, gene-based, and epigenetic therapies)</li><li>Immunotherapies (antibody and protein-based therapies)</li><li>Virus and vaccine therapies</li><li>Companion diagnostics and diagnostic assays</li><li>Protein therapeutics and bioassays</li></ul>Karen leads and mentors a multidisciplinary team of patent attorneys, agents, and scientific analysts, delivering strategic and comprehensive intellectual property services. Her practice includes:<ul><li>U.S. and international patent preparation and prosecution</li><li>Patent portfolio development and management</li><li>Patentability and freedom-to-operate analyses</li><li>Patent term extension strategies</li><li>Due diligence for investors and M&A transactions</li><li>Strategic counseling for startups, emerging, and established life sciences companies</li></ul>Karen is widely recognized for her ability to deliver pragmatic, creative patent solutions tailored to the unique needs of life sciences clients. She has been honored by publications for her leadership and innovative approach in biotechnology patent law.Before her legal career, Karen completed postdoctoral research at the La Jolla Institute for Allergy and Immunology and earned her Ph.D. in cellular and molecular biology from Duke University. Her scientific research has been published in leading peer-reviewed journals and presented at national conferences.

Karen Potter

Dr. Elizabeth (Liz) Newman focuses her work on patent drafting and assisting prosecution. She also has experience in IP due diligence inquiries, including freedom-to-operate analyses, with an emphasis on biotechnology and pharmaceuticals.Liz has worked with a wide range of clients, including startup biotech companies, large pharmaceutical companies, and universities. She has worked with clients in a number of areas, primarily in cancer immunotherapy.Liz received her Ph.D., dissertation awarded with honors, in microbiology and immunology from New York Medical College, where she studied antibody responses to influenza and concentrated on viral genomics, vaccine design, high throughput immunological assays including epitope mapping, molecular biology, and confocal microscopy.She received her B.S. in molecular and cellular biology from Mills College in Oakland, California.

Liz Newman

Patent Agent

Life Sciences + Healthcare

FDA + Healthcare Regulatory and Compliance