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Am Law 100 firm with practices in Business, Digital Assets and Data Management, Intellectual Property, Labor & Employment, Litigation and Tax.

Home | BakerHostetler

SCOTUS Holds that Job Transferees Need Only Show ‘Some Harm’ Under Title VII

BakerHostetler Shortlisted for Privacy & Data Security Law Firm of the Year by Chambers USA

Government Contractors and the Government’s FCA Enforcement Environment

BakerHostetler’s Sports Industry Honors Hank Aaron’s Home Run Record

Due to his significant experience with the complex FDA requirements, Winston is able to guide clients and their most significant deals through all aspects of FDA regulatory due diligence. He provides comprehensive advice to clients facing legal and regulatory challenges with products and services regulated by the FDA, including on how to address the FDA regulatory process.&nbsp;

Winston accumulated&nbsp;in-depth international legal and business life sciences experience through a variety of in-house positions at several large multinational biopharmaceutical companies, particularly in the areas of quality and compliance, regulatory affairs, compliance and ethics and legal affairs. This allows him to provide clients with a holistic view of their regulatory matters when combined with his knowledge of the regulatory process for pharmaceuticals, medical devices, foods and dietary supplements.

Winston previously served as the head of compliance and ethics, while based in London, for a multinational U.S. pharmaceutical company, and was responsible for business units comprised of Latin America, Central and Eastern Europe, Middle East-Asia-India, China&nbsp;and the Pacific Rim regions.

core/freeform

M.M.B.A., Biopharma Innovation, Rutgers University

J.D., Seton Hall University School of Law

B.S., Biology, Niagara University

<ul>
<li>Law360: Life Sciences Editorial Advisory Board (2024)</li>
<li>The Legal 500 United States
<ul>
<li>Key Lawyer in Healthcare: Life Sciences and Healthcare: Service Providers (2021)</li>
<li>Key Lawyer in Dispute Resolution: Corporate Investigations and White Collar Criminal Defense (2021 to 2022)</li>
</ul>
</li>
</ul>


Washington, D.C.

Winston Kirton Co-Chairs, Lee Rosebush Speaks at 2024 FDLI Annual Conference

Eight BakerHostetler Attorneys Named to 2024 Law360 Editorial Advisory Boards

Winston Kirton Moderates Panel on Health Equity

Winston Kirton Moderates Panel on the Business Case for Health Equity

Health Law Update

Healthcare Industry Team 2023 Year in Review

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products

Winston Kirton, Randal Shaheen Speak at Council for Responsible Nutrition Now New Next Event

FDA Forms Digital Health Advisory Committee to Navigate Emerging Technologies

Keeping tabs on federal scrutiny of dietary supplement, functional food industry

What in the World Is Happening with Drug Shortages, Decentralized Clinical Trials and M&A Transaction Diligence?

FDA Issues Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

FDA Issues New Guidance for Collecting Postmarketing Data on Underrepresented Patient Populations

Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty

Winston Kirton, Lee Rosebush and Francis Palumbo Attend 2023 FDLI Conference

Winston Kirton Moderates Food and Drug Law Panel on Due Diligence Amid Acquisition

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

Staying Ahead of the Curve in Biopharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions

BakerHosts

FDA Announces Impact of Ending COVID-19 Public Health Emergency

FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements

Winston Kirton Moderates BIO Roundtable on Clinical Trial Diversity

FDA Issues Guidance on Clinical Research with Cannabis

Note of Caution to Compounding Pharmacies

Winston Kirton Says Greater Clinical Trial Diversity Is Good Business, Should Be Incentivized

Winston Kirton and Lance Shea Speak at Food and Drug Law Institute Conference

FDA Issues Proposed Rule Updating “Healthy” Food Claim Definition

Winston S. Kirton Moderates FDLI Webinar on Impact of Supply Chain Disruption on FDA-Regulated Companies

BakerHostetler Continues Business Group Expansion, Adds FDA Partner Winston Kirton in Washington, D.C.

Winston Kirton Moderates Panel at FDLI Annual Conference

Winston Kirton Leads FDLI ‘Law Over Lunch’ Discussion on Due Diligence in Life Sciences Transactions

Winston Kirton Moderates FDLI Conference Panel: ‘Lessons Learned for Medical Products from COVID-19′

Winston Kirton Speaks at Pharmaceutical Compliance Congress

Winston Kirton Speaks on Third-Party Management at Compliance and Ethics Conference

Winston Kirton Authors Bloomberg Law Article on Improving Healthcare Access in Pandemic

Winston Kirton on FDLI Panel Discussing ‘Supply Chains in a Post-Pandemic World’

Winston Kirton Discusses Storage and Transport of Cold-Chain COVID-19 Vaccines

Winston Kirton Discusses Cannabis Legislation at FDLI ‘Law Over Lunch’

Winston Kirton Quoted in BioPharma Article on Biden’s Use of DPA for Supply Chain Issues

Business

Compliance

Government Investigations and Enforcement

Industries

Healthcare

Life Sciences

Mergers and Acquisitions

Private Equity

Pharmaceutical Pricing

Emerging Contaminants and Chemicals

<ul>
<li>Represented several private equity clients on acquisitions and sale of FDA regulated food, medical devices, biopharmaceuticals and dietary supplement products.</li>
<li>Represented pharmaceutical client on its acquisition of diabetes medical device asset.</li>
<li>Represented Danish pharmaceutical client on collaboration negotiations with U.S. medical device partner.</li>
<li>Conducted end-to-end compliance risk assessment of clients’ corporate operations in response to derivative suit settlement agreement.</li>
<li>Represented client in response to state compliance stop-use order for hand sanitizer distribution and sale.</li>
<li>Advised retail client on its strategy for introducing CBD products in stores nationally.</li>
<li>Advised client on regulatory strategy for introduction of foreign plant-based foods to U.S. market.</li>
<li>Advised client on FDA compliance requirements for labeling and marketing dietary supplement products for mothers.</li>
<li>Counseled client on FDA compliance requirements for labeling and launching a new line of liquid dietary supplements.</li>
<li>Advised and counseled UK client on FDA Investigational New Drug Application (IND) submission strategy for switching a non-U.S. dietary supplement product to a U.S. approved pharmaceutical.</li>
<li>Conducted risk assessment and advised client on its non-U.S. employee vaccination strategy.</li>
<li>Represented client in response to DOJ civil investigative demand and deposition.</li>
<li>Developed client’s enterprise-wide corporate compliance risk survey.</li>
<li>Helped client redesign its corporate compliance program including the development of sales force healthcare professionals (HCP) interactions policy.</li>
<li>Helped client develop Emergency Use Authorization (EUA) strategy for COVID-19 medical product introduction.</li>
<li>Assessed and redesigned client’s Code of Ethics and delivered employee training.</li>
<li>Helped client renegotiate its medical device supply agreement with key third-party alliance partner.</li>
<li>Conducted risk assessment of client’s third-party screening strategy and helped client redesign program.</li>
<li>Helped client successfully respond to FDA OCI subpoena.</li>
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