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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 146 results
Experience
|February 10, 2025
US$600 million Total Play Telecomunicaciones S.A.P.I. de C.V. Offer to Exchange Senior Notes
Experience
|January 29, 2025
Drugs Made In America Acquisition Corp. Announces Closing of $200,000,000 Initial Public Offering
Experience
|January 24, 2025
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Seminar/CLE
|May 13, 2025
2025 Health Care & Life Sciences Summit
Winston & Strawn is pleased to host its fifth annual Health Care & Life Sciences Summit. Clients and friends of the firm are invited to join us to network with peers and gain insights from industry leaders and legal experts. The summit will take place live at our Chicago office, and CLE-eligible recordings of the Summit’s sessions will be available shortly following the event.
Speaking Engagement
|May 9, 2025
Join Winston & Strawn partners M. Imad Khan and Keerthika M. Subramanian for the upcoming online program “Hot Topics in International Arbitration and Strategic Transactions: Recent Developments and Key Trends in India” hosted by the Practising Law Insititute.
Sponsorship
|April 22, 2025
Winston & Strawn Sponsors the Centri Capital Conference 2025
Winston & Strawn is proud to sponsor the inaugural Centri Capital Conference at Nasdaq in New York City. Attendees will engage with innovative companies across health care, life sciences, disruptive technologies, and more. The event will feature company presentations, one-on-one meetings, insightful panels, and fireside chats. Key topics include the capital market journey for disruptive companies, trends in venture capital, private equity, and private credit, the impact of AI on investors and issuers, and the role of cryptocurrency and blockchain in capital markets. Additionally, the event will explore upcoming global economic and regulatory changes.
Other Results 89 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.