Linda chairs the firm’s FDA Practice Group. She has extensive experience representing pharmaceutical, biotechnology, medical device manufacturers, and insurers on corporate and regulatory matters.
Linda advises health products manufacturers on the regulatory and reimbursement status of products and procedures and on strategic pathways for bringing new products to market. She counsels clients on compliance with the Federal Food, Drug, and Cosmetic Act and related requirements, including arrangements for outsourced services, advertising and other promotional issues, and responses to 483s and Warning letters.
She also provides advice on the regulatory issues relating to in vitro diagnostic products, including laboratory developed tests (LDTs) and companion diagnostics. She performs regulatory due diligence for financings and other corporate transactions and counsels clients on disclosure of clinical and other product information. In addition, she has worked with companies to obtain reimbursement from insurance companies, managed care organizations, and Medicare.
She serves as general counsel to a large municipal self-insurance pool. She has also assisted insurance companies in obtaining initial state licensure, amendments to existing licenses, insurance department approval of mergers and acquisitions, and responding to enforcements actions.
After graduating from law school, Linda served as senior counsel for the Massachusetts Division of Insurance, where she focused on the regulation of health insurance products and managed care organizations. She also advised the commissioner of insurance on insurance transactions, such as mergers and acquisitions, holding company filings, and agent, broker, and company licensing.
Before attending law school, Linda worked for eight years at New England Nuclear/DuPont Medical Products, where she served as director of regulatory affairs from 1976 to 1980. In that capacity, she established and implemented the company’s FDA policy and was responsible for obtaining marketing approval for new products in the United States, Canada, and other countries. She continued to provide FDA consulting services to pharmaceutical and medical device companies while she was in law school.
Recognitions & Awards
- Massachusetts Super Lawyers: FDA (2004 – 2007, 2009)
- Martindale-Hubbell AV Preeminent
Professional & Community Involvement
- Member, American Health Lawyers Association
- Member, Massachusetts Bar Association
- Member, Boston Bar Association
- Former director, Massachusetts Medical Device Industries Council (MassMEDIC)
- Member, MassMEDIC Advisory Committee on In Vitro Diagnostics
- Director, MedTech IGNITE, a MassMEDIC program for medical device entrepreneurs
- Member, Advisory Board of BNA’s Pharmaceutical Law & Industry Report
Linda chairs the firm’s FDA Practice Group. She has extensive experience representing pharmaceutical, biotechnology, medical device manufacturers, and insurers on corporate and regulatory matters.
Linda advises health products manufacturers on the regulatory and reimbursement status of products and procedures and on strategic pathways for bringing new products to market. She counsels clients on compliance with the Federal Food, Drug, and Cosmetic Act and related requirements, including arrangements for outsourced services, advertising and other promotional issues, and responses to 483s and Warning letters.
She also provides advice on the regulatory issues relating to in vitro diagnostic products, including laboratory developed tests (LDTs) and companion diagnostics. She performs regulatory due diligence for financings and other corporate transactions and counsels clients on disclosure of clinical and other product information. In addition, she has worked with companies to obtain reimbursement from insurance companies, managed care organizations, and Medicare.
She serves as general counsel to a large municipal self-insurance pool. She has also assisted insurance companies in obtaining initial state licensure, amendments to existing licenses, insurance department approval of mergers and acquisitions, and responding to enforcements actions.
After graduating from law school, Linda served as senior counsel for the Massachusetts Division of Insurance, where she focused on the regulation of health insurance products and managed care organizations. She also advised the commissioner of insurance on insurance transactions, such as mergers and acquisitions, holding company filings, and agent, broker, and company licensing.
Before attending law school, Linda worked for eight years at New England Nuclear/DuPont Medical Products, where she served as director of regulatory affairs from 1976 to 1980. In that capacity, she established and implemented the company’s FDA policy and was responsible for obtaining marketing approval for new products in the United States, Canada, and other countries. She continued to provide FDA consulting services to pharmaceutical and medical device companies while she was in law school.
Recognitions & Awards
- Massachusetts Super Lawyers: FDA (2004 – 2007, 2009)
- Martindale-Hubbell AV Preeminent
Professional & Community Involvement
- Member, American Health Lawyers Association
- Member, Massachusetts Bar Association
- Member, Boston Bar Association
- Former director, Massachusetts Medical Device Industries Council (MassMEDIC)
- Member, MassMEDIC Advisory Committee on In Vitro Diagnostics
- Director, MedTech IGNITE, a MassMEDIC program for medical device entrepreneurs
- Member, Advisory Board of BNA’s Pharmaceutical Law & Industry Report
Publications
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Author,
FDA Draft Guidance on In Vitro Companion Diagnostic Devices Provides an Outline but Few Specifics to Advance the Growth of Personalized Medicine, Life Sciences | FDA Alert ()
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Author,
New Guidance on RUOs and IUOs May Affect LDTs, Life Sciences | FDA Alert ()
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Author,
FDA Releases Criteria for Responsible Officer Prosecutions, Life Sciences Alert ()
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Co-author,
New Proposed HIPAA Rules May Benefit Researchers, Health Law Advisory ()
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Co-author,
New Proposed HIPAA Rules May Benefit Researchers, Life Sciences Advisory ()
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Author,
Life Sciences Industry Extra: Federal Funding Opportunity for Orphan Products, ()
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Co-author,
Communications and Health Care Article: Radio Frequency Medical Devices at the Intersection of FCC, FDA and Privacy Concerns, Update Magazine ()
Speaking Engagements
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Chair,
Accelerating the Clinical Route to NDA/BLA Submission,
The Massachusetts CRO/CMO Symposium: Accelerating Drug Development,
Massachusetts Biotechnology Council, Newton, MA
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Panelist,
Biosimilar Regulations and CMOs,
FierceBiotech, Webinar
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Speaker,
The Health Care Reform Law: Implications for the Medical Device Industry,
Massachusetts Medical Device Industry Council, Webinar
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Chair,
Diagnostics —The Wave of the Future,
AdvaMed 2009,
AdvaMed
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Personalized Medicine: The Wave of the Future,
AdvaMED Annual Meeting,
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Current Regulatory Hurdles Facing Start-Ups,
MedTech IGNITE Meeting,
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Speaker,
Diagnostic Industry Update: Trends and Issues,
MassMEDIC , Waltham, MA
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What Every SEC Lawyer Should Know About the FDA,
Mintz Levin
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Speaker,
The Voluntary Codes: AdvaMed, PhRMA, AMA & the OIG,
Are You Ready to Comply with Massachusetts' New Pharmaceutical and Medical Device Code of Conduct La,
MassMEDIC , Boston, MA
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Speaker,
Human Clinical Trials: Opportunities to Align Clinical Trials in the US, China, and India,
MassInsight US-India-China Innovation Partnerships Conference,
Boston, MA
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Wireless Life Sciences Alliance Meeting,
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Conflicts of Interest in Drug Research,
Food and Drug Law Institute Annual Meeting,
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FDA Regulation of Diagnostic Tests and In Vitro Diagnostic Multivariate Index Assays: FDA Draft Guidance,
Client Presentation,
Newsroom
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Quoted in
Tightening Oversight, Modern Healthcare ()
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Quoted in
Critics Charge That Drug-Compounding Pharmacies Require Government Oversight, The Washington Post ()
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Quoted in
Compounding Pharmacies: Where’s the Oversight?, MedPage Today ()
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Quoted in
Disease Outbreak All Too Common, USA Today ()
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Quoted in
Meningitis Outbreak Puts Attention on Pharmacy Rules, The Tennessean ()
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Quoted in
What Are Compounding Pharmacies?, Web MD ()
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Quoted in
Md. Specialty Pharmacies Seek Distance from Meningitis Outbreak, The Baltimore Sun ()
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Quoted in
Relocating Abroad, Modern Healthcare ()
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QuotedIn
FDA Releases Strategic Priorities That Will Guide Agency Through 2015, BNA's Pharmaceutical Law & Industry ()
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Quoted in
PLIR Advisory Board Sees Biosimilars, Enforcement Among Top Concerns for 2011, BNA's Pharmaceutical Law & Industry ()
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Mintz Levin Represents Alphatec Holdings, Inc. in $92 Million Public Offering, ()
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Mintz Levin Represents Oppenheimer & Co., Inc. in Back-to-Back Closings of Two Offerings, ()
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Forty-Eight Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, ()
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Mintz Levin Represents Targacept Inc. in Public Offering, ()
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Forty-Five Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, ()