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FDA + Healthcare Regulatory and Compliance

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Our FDA attorneys advise clients in the life sciences and healthcare industries, helping them navigate complex regulatory, compliance issues and more.

Case Studies

FDLI’s Enforcement, Litigation, and Compliance Conference

29th Annual Conference on Drug & Medical Device Litigation

Retail Industry Leaders Association (RILA) Retail Law Conference 2024

2024 Food and Drug Law Institute’s Food Advertising, Labeling, and Litigation Conference

The Fate of FDA Authority: Addressing Recent Supreme Court Decisions on Mifepristone, Chevron, and Beyond

BIO International Convention 2024

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Implied Preemption for Dietary Supplements Is Here to Stay

Non-Lab Diagnostics: FDA Regulatory Considerations

At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, and Distribution Agreements

Non-Lab Diagnostics: Consumer and User Agreements

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

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Morrison Foerster’s FDA + Healthcare Regulatory and Compliance Group Recognized by Chambers USA 2024 and The Legal 500 2024

In Chevron’s Fall, Attys See Conflicting Rulings, Circuit Splits

Morrison Foerster Shortlisted in 20 Categories for the Americas Women in Business Law Awards 2024

Ex-FDA Chief on Election Year Healthcare Policy

Morrison Foerster Recognized by JD Supra Readers’ Choice Awards 2024

5 Considerations When Licensing Cell Or Gene Therapy Products

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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 a member 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

When Your Life Sciences Are on the Line: Life Sciences and Food + Agriculture

Toward a Therapy for COVID-19: The Science and Legal Considerations

Toward a Vaccine for COVID-19: The Science and Legal Considerations

Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

FDA + Healthcare Regulatory and Compliance

District of Columbia: Healthcare: Pharmaceutical/Medical Products Regulatory

Industry Focus: Healthcare: Life Sciences

Shortlisted for FDA Litigation & Enforcement Firm of the Year

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