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- Alicia Duncan
- Assistant GC and Chief Ethics Officer
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Assistant GC and Chief Ethics Officer
Capabilities 77 results
Industry
The medical device industry is currently undergoing monumental change—from supply chain challenges to disruptive technologies and economic fluctuations. To pave the way for a more accessible and innovative health care landscape—including advances in wearables, implants, diagnostics, mobility, drug delivery—the evolving and expansive medical device industry faces wide-ranging legal needs. Clients in this sector can tap the remarkable depth and breadth of our sector-focused and skilled attorneys in the U.S. and abroad. Our Health Care & Life Sciences Industry Group engages clients at all points in the product development life cycle to provide sound advice and practical solutions regardless of the client’s size or the complexity of their need. We help clients navigate today’s complex regulatory landscape, defend products and reputations in the face of high-profile product liability and mass tort claims, protect innovative intellectual property (IP), and leverage cross-border experience to advise on commercial transactions.
Industry
Winston’s financial crimes compliance lawyers have been providing regulatory compliance counseling and enforcement services related to the Bank Secrecy Act (BSA), the Anti-Money Laundering Act of 2020 (AML), and countering the financing of terrorism (CFT) policy for decades. We also have experience with international AML matters, including in the EU and with respect to Financial Actions Task Force (FATF) recommendations.
Industry
Experience 118 results
Experience
|February 16, 2024
Winston Represented Whitsons Culinary Group in its Acquisition of Fresh Picks Café
Experience
|January 16, 2024
Winston Represented Arthur J. Gallagher & Co. in its Acquisition of The Rowley Agency
Experience
|January 1, 2024
Insights & News 5,265 results
Sponsorship
|May 15, 2024
Winston & Strawn Sponsors EF Hutton Annual Global Conference
Winston & Strawn is sponsoring the EF Hutton Annual Global Conference, which will feature innovative public and private companies from multiple industries in a close-knit, personalized setting. Instead of general presentations, the event adopts a one-on-one format. Key executives from public and private companies will share their distinctive stories with a diverse audience consisting of institutional investors, high-net-worth individuals, corporate clients, and select press members.
Sponsorship
|May 9, 2024
Winston & Strawn Sponsors, Chris Gavin Speaks at IMN MBS Forum 2024
Winston & Strawn is a proud sponsor of the IMN MBS Forum 2024, a specialized event focusing on high-quality educational content and networking opportunities for financial institutions and mortgage practitioners looking at the full potential of the U.S. mortgage market.
Sponsorship
|May 7, 2024
Winston & Strawn Sponsors 2024 IP Counsel Café Meeting
Winston & Strawn is proud to sponsor the IP Counsel Café Annual Meeting in Silicon Valley, California, from May 7-9, 2024. Partners attending include Robert Kang, Mike Rueckheim, and Saranya Raghavan.
Other Results 69 results
Law Glossary
What Is the Standard for the FDA to Grant a Generic Drug License?
An Abbreviated New Drug Application (ANDA) must contain evidence that the proposed generic drug product is bioequivalent to the reference drug.
Law Glossary
What Is the Approval Process for Generic Drugs?
Approval for generic drugs are governed by the Hatch-Waxman Act. The Hatch-Waxman Act provides the framework for an applicant to demonstrate that its proposed generic product is bioequivalent to the brand-name drug.
Law Glossary
Generic drugs are typically small, chemically synthesized molecules—that is, they have relatively low molecular weights, frequently less than 1000 daltons and usually between 300 and 700 daltons. Biosimilars, on the other hand, are typically substantially larger in molecular weight than small molecule drugs. For example, a monoclonal antibody—a typical biosimilar drug—generally has a molecular weight in excess of 150,000 daltons. In contrast, aspirin—a typical small molecule drug—has a molecular weight of 180 daltons.