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FDLI’s Enforcement, Litigation, and Compliance Conference

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Morrison Foerster is a proud sponsor of FDLI’s 2024 Enforcement, Litigation, and Compliance Conference. This event brings together regulators, attorneys, litigators, academics, and consultants and other stakeholders to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements.

Morrison Foerster is a proud sponsor of FDLI’s 2024 Enforcement, Litigation, and Compliance Conference. This event brings together regulators, attorneys, litigators, academics, and consultants and other stakeholders to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements.On Tuesday, December 10, from 11:20 a.m. to 12:20 p.m., Brigid Bondoc, partner and chair of Morrison Foerster’s FDA + Healthcare Regulatory and Compliance practice, will speak on the Medical Device and Digital Health Enforcement Update panel. This session will survey recent developments in enforcement activity involving both traditional medical devices and digital health technologies and consider areas for potential future enforcement. Speakers will examine recent criminal enforcement matters involving medical device companies and their executives, including the underlying charging theories and efforts by the U.S. Department of Justice.On Wednesday, December 11, from 11:45 a.m. to 12:45 p.m., Atiq Chowdhury, an associate in the firm’s FDA + Healthcare Regulatory and Compliance practice, will speak at the Virtual Reality: Cybersecurity and FDA Obligations panel. Over the last decade, the FDA has issued several draft and final guidance documents related to cybersecurity, and Congress has begun to legislate additional requirements as the observed risk of cyberattacks has grown. Attendees will learn about compliance and enforcement risks, both observed and potential, based on cyber vulnerabilities, and FDA requirements with respect to a cybersecurity data breach incident.For additional information or to register, please visit the <a href="https://www.fdli.org/2024/12/2024-enforcement-litigation-and-compliance-conference/" target="_blank">conference website</a>.<hr>

For the Drug, Device, Food, and Tobacco Industries

FDLI’s Enforcement, Litigation, and Compliance Conference

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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

Atiq Chowdhury is an associate in the FDA + Healthcare Regulatory and Compliance practice, where he advises FDA-regulated companies on a wide range of regulatory, enforcement, and compliance matters. He counsels pharmaceutical, medical device, and food companies on FDA regulatory requirements, fraud and abuse issues, states’ corporate practice of medicine and licensing matters. Atiq focuses on assisting clients in the diagnostics, software as a medical device, mobile medical applications, and medical technology fields in becoming compliant with the Federal Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments. Prior to joining Morrison Foerster, Atiq practiced at other leading international law firms. For more than a decade, he also worked in reviewer and policy roles at the U.S. Food and Drug Administration (FDA). In these roles, he reviewed Premarket Approval notifications and applications, Investigational Device Exemptions, Q-Submission requests, and promotional and compliance issues, and contributed to guidance documents and other agency policy priorities. He also served as a Commissioned Corps Officer in the U.S. Public Health Service (PHS) for nearly a decade. While at the FDA, Atiq was honored by the FDA Center for Devices and Radiological Health (CDRH) with the Special Recognition Award for MDUFA III Assessment and Implementation and the Excellence in Compliance and Enforcement Award. He also received Commendation and Citation medals from the PHS for his contributions to approving and clearing first-of-their-kind diagnostic and therapeutic devices.Atiq’s experience has included, for example:<ul><li>Assisting clients with interactions between FDA and other global health authorities related to drug and device submissions (e.g., Investigational New Drugs, New Drug Applications, Q-Submissions, 510k applications, Investigational Device Exemptions, De Novo submissions, and Premarket Approval applications).</li><li>Advising clients on FDA regulations and global regulatory strategies related to the development of drug, device, and combination product marketing applications which include software applications, companion diagnostics, diagnostic tests, biomarkers, and digital health tools.</li><li>Advising medical device and pharmaceutical facilities on preparation for FDA inspections or responding to FDA Form 483 observations, import alerts, and warning letters, as well as developing site remediation work plans.</li><li>Performing gap assessments for device and drug manufacturers across a range of quality systems, including complaint handling, corrective and preventive actions, good documentation practices, supplier management, and adverse event safety reporting.</li><li>Supporting internal investigations concerning alleged cGMP/QSR compliance violations at FDA-regulated manufacturing facilities based in the United States, Europe, and Asia.</li><li>Representing and advising large healthcare and life sciences companies, as well as small biotech and medtech companies, on acquisitions, mergers, joint ventures, and other arrangements.</li></ul>

FDLI’s Enforcement, Litigation, and Compliance Conference

10 Dec 2024 - 11 Dec 2024