Sonali draws on nearly ten years of experience as an attorney at the U.S. Food and Drug Administration (FDA) to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. She gives her clients the benefit of her deep knowledge of the law and a keen, forward-looking sense of how FDA may view a particular matter, giving the client the ability to develop the most effective and persuasive approach to any situation.
Her practice focuses on:
- The rapidly changing FDA regulatory requirements for bringing medical devices and pharmaceuticals to market;
- The complex emerging rules applicable to domestic and foreign food manufacturers, suppliers and importers;
- Clinical trial compliance requirements for pharmaceutical and medical device studies; and
- The defense of FDA enforcement actions against pharmaceutical, medical device, food, and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions and individual researchers.
Sonali counsels clients on regulation of medical devices; food and pet food regulation; pharmaceutical approvals; dietary supplements; and FDA enforcement defense. In addition to her experience at FDA, Sonali served as an attorney advisor at the U.S. Patent and Trademark office.
Before joining Shook, Sonali was of counsel for Wiley Rein LLP.
- Counsels clients on the FDA regulatory system for the review and authorization of medical devices, drawing on her firsthand knowledge of the complexities and impacts of FDA’s informal and often unwritten policies and practices.
- Counsels clients on the regulatory process, on how best to respond to enforcement actions, including critical initial responses to FDA Form 483s, and strategies for submission of comments on proposed rulemaking.
- Experienced in FDA regulation of medical devices, having served more than seven years at the Center for Devices and Radiological Health (CDRH) where she served as manager of the CDRH Application Integrity Policy Program (AIP) and as the integrity officer for the Division of Research Monitoring.
- At CDRH, coordinated the review and approval of guidance documents; exercised supervisory review of all proposed warning letters, untitled letters and AIP enforcement actions against medical device sponsors, clinical investigators, good clinical laboratories and the Institutional Review Boards; initiated enforcement recommendations with respect to advertising and promotional practices for marketed and investigational devices.
- Works with pharmaceutical companies on a myriad of issues, including pre-submission materials, responses to FDA during the review cycle and regulatory actions, including responses to FDA Form 483s and Warning Letters.
- Assists pharmaceutical companies with appropriate and FDA-compliant branding, labeling, advertising and promotion of both investigational and marketed products.
- Assists with understanding and strategically navigating cited FDA regulatory violations in order to assist companies and corporate officials facing prosecution under the Responsible Corporate Officer Doctrine, known as the Park Doctrine.
- During her tenure at FDA, served several special duty assignments in the Center for Drug Evaluation and Research, including in the Office of Compliance and the Office of Medical Policy.
Food Safety Regulation
- Works with food and pet food companies and associations on issues such as safety, nutrition and health, labeling, good manufacturing practice (GMP), packaging, biotechnology and the use of risk assessment and risk management in regulation of the safety of food components.
- Served in FDA’s Center for Food Safety and Applied Nutrition, where she was immersed in numerous aspects of food safety policy and regulatory implementation related to the Food Safety Modernization Act (FSMA).
- Served as the lead regulatory counsel and regulation writer on both the Sanitary Food Transportation Act Proposed Rule and the Product Tracing Proposed Rule under FSMA.
- Assists clients with complex issues, including the interpretation of the statutory definition of “dietary supplement,” the application of the “new dietary ingredient” criteria, permitted “structure” or “function” claims, and impermissible “disease” claims.
- Also counsels clients on general labeling issues, GMP compliance, and the distinction between labeling and advertising.
- During her tenure with FDA, worked closely with the Office of Nutrition, Labeling, and Dietary Supplements to usher through the New Dietary Ingredients Draft Guidance under FSMA.
Clinical Trial Experience
- Counsels clients in strategies for the best course of action when regulatory correspondence is issued by FDA, based on her previous experience as Regulatory Counsel for the Division of Bioresearch Monitoring.
- Worked closely with medical device companies and their counsel to address issues of noncompliance by submission of adequate corrective action plans.
FDA Enforcement Defense
- Counsels clients in all stages of FDA inspections, including product recalls and enforcement actions before the agency.
- Knowledgeable about the difference current Good Manufacturing Practices (cGMP) and clinical trial compliance strategies and programs FDA field investigators use during inspections; worked closely with the FDA district offices responsible for conducting inspections of medical device manufacturers, institutional review boards, clinical investigators and contract research organizations.
Intro to COVID-19: Enforcement Action Guidelines, Legal Liabilities and Concerns, Food and Drug Law Institute, August 18, 2020 (with Angela Seaton).
Enforcement and Compliance, Introduction to Medical Device Law and Regulation, Food and Drug Law Institute, Washington, D.C., November 13, 2019.
MedTechDevices, 60 Seconds of Legal Science, July 25, 2019.
Medical Device Cybersecurity: How the U.S. Food and Drug Administration and Other Stakeholders Are Collaborating to Increase Patient Safety, Update of the Law CLE, Kansas City, Missouri, June 13, 2019 (with Colman McCarthy).
Product Development and Quality System Regulation, Introduction to U.S. Medical Device and IVDs Law and Regulation, Centers for Disease Control, Atlanta, Georgia, April 23, 2019.
Cybersecurity Law and Practice, and Its Implication for Today's IoT Devices, 32nd Annual National Bar Association-Commercial Law Section Corporate Counsel Conference, Orlando, Florida, January 31, 2019.
Regulatory Framework Overview, BioBreakfast: Navigating the Life Science Regulatory Pathway, Colorado BioScience Association, Boulder, Colorado, December 5, 2018.
Manufacturing and Quality System (QS) Regulation, and International Issues, Food and Drug Law Institute, Washington, D.C., November 8, 2018 (with Sean Lee).
Recent Enforcement Trends in Life Sciences - Understanding Areas of Concern from Advertising/Promotion to Competition and GMP Enforcement, ABA Life Sciences Summit, San Francisco, September 26, 2018 (with Steve Vieux).
Medical Device Innovations: Welcome to the Future, Food and Drug Law Institute Annual Conference "Exploring Advanced Topics in Food and Drug Law," Washington, D.C., May 3, 2018 (with Vernessa Pollard, Zachary Rothstein, Bakul Patel and Suzanne Schwartz).
Enforcement and Compliance, Food and Drug Law Institute's Introduction to US Medical Device Law and Regulation, Washington, D.C., April 13, 2018.
Review of FDA’s Guidance on Quality Agreements and Best Practices to Ensure Your Supply Chain is Secure, Process Validation 2018 Summit, Philadelphia, Pennsylvania, May 18, 2018.
Cybersecurity and the Consumer Product and Medical Device Industries, Webinar for Stericycle, January 25, 2018.
Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries, Food and Drug Law Institute, Washington, D.C., December 7, 2017.
Enforcement and Compliance, FDLI Introduction to U.S. Device Law and Regulation, Washington, D.C., November 3, 2017.
Incorporating Cybersecurity Into the DNA of Telehealth, FCBA CLE Seminar, Cybersecurity and the Internet of Things: Policy Challenges Across Sectors and in Telehealth, Washington, D.C., October 11, 2017.
(Recall for dog treats), FDLI New to FDA Law Lunch Series, Washington, D.C., October 10, 2017.
(Cybersecurity issues for medical devices), Stericycle Advisory Group Meeting, Princeton, New Jersey, October 3, 2017.
Recall Fundamentals and How to Improve Recall Strategies From Start to Finish, Life Science’s 13th Annual Product Recalls Summit, Arlington, Virginia, September 25, 2017.
FDA Device Law 101: Introduction to the Fundamentals and Resolving Ethical Challenges Encountered During the Device Approval Process, ACI’s 5th Annual FDA Boot Camp Devices Edition, Chicago, Illinois, July 26, 2017.
The Changing Landscape of IoT: Medical Device Privacy and Cybersecurity, FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law, May 5, 2017.
510(k) Post-Clearance Process, AdvaMed 510(k) Submissions Workshop, Irvine, California, February 28, 2017.
Sweets and Spice and Labeling Nice—FDA Guideline Changes, 48th Annual CASBA Convention, Orlando, Florida, February 20, 2017.
International Issues, FDLI Introduction to Medical Device Law and Regulation, Washington, D.C., November 3, 2016.
End Users & Reliability Issues, NBMC Workshop: Blood, Sweat & Tears III, Arlington, Virginia, November 2, 2016.
Introduction to Medical Device Law and Regulation Workshop: Understanding How FDA Regulates the Medical Device Industry, FDLI/CDRH In-House Training, Silver Spring, Maryland, October 28, 2016.
Direct-to-Consumer Advertising: A Force for Good? The FDLI Advertising and Promotion Conference, Washington, D.C., September 27, 2016.
Medical Device Cybersecurity: How the US Food and Drug Administration and Other Stakeholders are Collaborating to Increase Patient Safety, FDLI Update, April/May 2019 (with Margaret Horn); reprinted with the permission of FDLI.
Pharmaceutical Advertising 2019: Trends and Developments, Chambers and Partners Practice Guide, February 20, 2019 (with Hildy Sastre, Jennise Stubbs and Alyse Zadalis).
Medical Device Cybersecurity: Preparing For The Worst, Law360, April 23, 2018 (with Chris Harvey).
The Vexing Problem of Defining Intended Use: A Proposed Solution, Bloomberg Law’s Medical Devices Law & Industry Report, February 15, 2018 (with Bert W. Rein).
The U.S. FDA’s Final Guidance on Postmarket Management of Cybersecurity in Medical Devices: The Important Changes to Note, Digital Health Legal, February 2017.
“‘Thinking Ahead’: Shook Hardy Attorney Gets Quick FDA OK to Switch Apnea Devices to Ventilators,” Daily Business Review, April 10, 2020.
“FDA Warns Against False Advertising for Covid-19 Antibody Tests,” Bloomberg Law, April 8, 2020.
“Clinical Trials May Hit Standstill to Focus on COVID-19,” Bloomberg Law, March 26, 2020.