BACKGROUND
FOCUS AREAS
More than 18 years of experience advising FDA-regulated entities, investors, and public health organizations on a broad range of FDA regulatory matters.
FDA statutes, regulations, and policy
Development, clearance and approval, and marketing of FDA-regulated products
FDA regulation of in vitro diagnostics and laboratory-developed tests
FDA regulatory due diligence
FDA regulation of digital health
FDA regulatory policy
Litigation support
Maura Norden brings over 18 years of extensive FDA regulatory experience to her role at ELIQUENT Life Sciences. Maura joined Greenleaf, Inc. (now ELIQUENT Life Sciences) from the law firm Sidley Austin LLP in 2015, following nearly a decade counseling leading medical device and drug companies and investors on a broad range of FDA regulatory matters.
Maura uses her comprehensive and in-depth understanding of the FDA’s statutory jurisdiction, regulatory requirements, and regulatory processes to provide strategic and tactical advice to FDA-regulated companies throughout the product lifecycle, from development to FDA premarket review and postmarket regulation. Maura advises a broad range of clients, including early-stage companies, large, multinational industry leaders, trade associations, and public health groups. She also co-leads the Digital Health and Litigation Support teams at ELIQUENT.
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EDUCATION:
Bachelor of Arts, The University of Virginia
Juris Doctor, The George Washington University Law School -
PROFESSIONAL EXPERIENCE:
Maura’s experience includes advising:
– Digital health companies on the FDA’s evolving approach to digital health products;
– Consumer technology companies with respect to potential FDA regulation under the medical device provisions of the Federal Food, Drug, and Cosmetic Act;
– Clinical laboratory clients regarding the FDA’s historical and current policies related to laboratory-developed tests (LDTs);
– FDA-regulated firms on compliance with FDA promotional requirements, drawing on experience gained during temporary assignments to multinational pharmaceutical companies, where she sat on copy review committees;
– Cosmetics companies with respect to permissible claims for cosmetic products;
– Investors in connection with due diligence for transactions;
– Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents; and
– In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues.
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