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Alexandre Gapihan

アソシエイト

Washington, DC 電話 +1.202.739.5063 Fax +1.202.739.3001

1111 Pennsylvania Ave. NW//Washington, DC 20004-2541//United States

Alexandre Gapihan’s practice is primarily focused on matters relating to the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the pharmaceutical industry, including the approval, regulation, promotion, and sale of drugs, medical devices, and dietary supplements. Alexandre excels in assisting clients in navigating the complex legal and regulatory frameworks that impact their business.

Prior to joining Morgan Lewis, Alexandre was an associate at another international law firm. He is a native French speaker and is conversational in Mandarin Chinese.

受賞・所属

Ones To Watch, Government Relations Practice, Washington DC, The Best Lawyers in America (2023)

弁護士登録

  • District of Columbia
  • Pennsylvania
  • New Jersey
  • US District Court for the Eastern District of Pennsylvania

学歴

  • 2015年 University of Pennsylvania Law School (J.D.)
  • 2015年 University of Pennsylvania, Wharton School of Business (Certificate of Study in Business Economics and Public Policy)
  • 2008年 Vassar College (B.A. International Studies and Economics)

セクター

取扱分野

地域

イベント

2/23/2023 - Fast Break: Personalized Medicine and Clinical Trials in 2023
4/22/2022 - Origins and Overview of Drug Law Regulation: An Introduction
11/9/2021 - FDLI's Introduction to Drug Law and Regulation – November 2021

ニュース

9/19/2022 - Morgan Lewis Advises on $200 Million Revance Therapeutics Public Offering

著書・論文

2/21/2023 - FDA Releases Final Guidance on Quality Considerations for Cannabis in Clinical Research
2/17/2023 - FDA Issues Final Guidance on Quality Considerations for Clinical Research on Cannabis and Related Compounds in Drugs
9/29/2022 - Eat Your Greens: FDA Proposes New Definition for ‘Healthy’ Packaged Food Claims
5/25/2022 - One License to Unite Them All: FDA Proposes National Standards for Wholesale Distributors and Third-Party Logistic Providers
2/8/2022 - After a Series of False Starts, FDA Resumes Domestic Inspections
11/11/2021 - FDA Grants First E‑Cigarette PMTA Authorization
10/26/2021 - New US Department of Agriculture Initiative to Combat Salmonella in Poultry
9/28/2021 - USDA Bioengineered Food Disclosure Rule Goes Into Effect on January 1, 2022
9/20/2021 - Tracking Back to Track and Trace: Additional Guidance on Compliance with the DSCSA
6/11/2021 - FDA Reinstates Unapproved New Drug Initiative
6/1/2021 - Bipartisan Group of Senators Introduces Bill to Regulate Hemp and Hemp-Derived CBD in Food
5/19/2021 - Heme-Burgers and Hot Dogs: Ninth Circuit Affirms FDA’s Approval of Plant Meat Color Additive
5/12/2021 - Zooming in on Inspections: FDA Issues Guidance on Remote Interactive Evaluations and Roadmap on Inspectional Oversight
1/28/2021 - FDA Places Mexican-Made Hand Sanitizers on Import Alert Due to Toxin Risks
7/28/2020 - Burger King Has Its Way: Vegan Whopper Class Action Suit Dismissed
5/7/2020 - FSIS, FDA Announce More Flexibility in Regulatory Requirements During Pandemic
4/17/2020 - FSIS, FDA Provide Flexibility with Temporary Guidance
4/6/2020 - In Continued Hand Sanitizer Shortage, FDA Issues Additional Guidance for Manufacture of Alcohol
3/26/2020 - FDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand Sanitizer Products
2/20/2020 - Mexico’s New Labeling Rules Will Impact Marketers and Importers of Prepackaged Foods, Nonalcoholic Drinks
1/9/2020 - A Rose by Any Other Name? FDA Renames and Restructures Office of Hematology and Oncology Products
12/10/2019 - California Prop 12 Animal Protection Law Survives Initial Legal Challenge
10/25/2019 - FDA Grants a Six-Month Enforcement Discretion Extension on Nutrition Fact Label Change Requirements
6/20/2019 - FDA Clarifies Premarket Path for Ecigarette Products