June 13, 2021

Volume XI, Number 164

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June 11, 2021

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Health Law Diagnosed — Hot Topics in FDA Regulation and Enforcement [PODCAST]

This past year has been a busy one for the FDA, but it hasn’t all been about the pandemic. FDA attorneys Joanne Hawana and Benjamin Zegarelli discuss the agency's ongoing efforts to protect the public from unproven COVID-19 cures while also pushing forward with its most important regulatory priorities, such as digital health, cannabis-derived compounds, and laboratory-developed tests and other diagnostic products.

©1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XI, Number 132
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TRENDING LEGAL ANALYSIS

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About this Author

Nili Yolin Corporate and Healthcare Law Attorney Mintz Levin
Member

Nili helps health care clients understand and navigate the regulatory environment in order to maximize their business opportunities. She draws on her knowledge of federal and state laws to help clients structure complex transactions, design and implement compliance programs, and enter into professional services, consulting services and other arrangements that reduce their risk of liability under intricate regulatory frameworks such as corporate practice of medicine, anti-kickback, and self-referral (Stark) laws.

Nili counsels hospitals, large and small group practices, community-...

212-692-6799
Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

202.434.7349
Benjamin Zegarelli Health Care Attorney Mintz Levin
Associate

Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships.

Benjamin has experience representing medical device companies in responding to significant unfavorable inspection observations, sometimes...

212-692-6261
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