Fashion Counsel with Anthony V. Lupo

Arent Fox's fashion law blog offers news, analysis, and insights for the industry from fashion attorney Anthony Lupo.

Fashion Counsel with Anthony V. Lupo

Naomi J. L. Halpern

Naomi J. L. Halpern
Counsel
Washington, DC
202.857.6464

Naomi Halpern’s practice involves advising clients on a broad range of regulatory issues involving the Food and Drug Administration (FDA) with respect to pharmaceuticals (including branded and generic prescription and over-the-counter drugs), medical devices, foods, cosmetics, and dietary supplements. She also advises on the laws and regulations relating to consumer products administered by the US Consumer Product Safety Commission (CPSC).

Client Work

Naomi counsels clients on issues relating to all phases of product development and approval, from the investigational stage to regulatory compliance and post-marketing, as well as on rulemaking, and enforcement proceedings. She also has experience in evaluating and advising with respect to marketing strategies for new products (including review and counseling on advertising and promotional materials and strategies), reporting and recordkeeping requirements, clinical trial requirements, recalls and market withdrawals, drug and device listing and registration, user fees, and orphan therapy issues. Additionally, she counsels clients and has significant experience with laws and regulations of the CPSC, as well as with both federal and state laws related to medical privacy.

Previous Work

Prior to joining Arent Fox, Naomi was a partner in the Washington office of a New York-based law firm specializing in intellectual property and regulatory law and counsel at a Washington-based boutique law firm specializing in FDA and USDA law.

Professional Activities

Naomi is a member of the American Bar Association and the Administrative Law and Regulatory Practice Section. She is also a member of the Editorial Advisory Board for the Update Magazine, published by the Food and Drug Law Institute.

 

Blog Posts by Naomi J. L. Halpern

Advertising, Data Collection & Privacy
alert
Ho-Ho-Ho! Retailers Beware When Advertising
Retailers should beware this holiday season – and beyond – when advertising sales using a comparison between the “original” and “sale” prices as Macy's, Sears, and JC Penney were just sued by the Los Angeles City Attorney for allegedly deceiving consumers by using a false original “reference price.”

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Consumer Product Safety
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Congress Considering Legislation Giving FDA Additional Regulatory Authority Over Cosmetics and Personal Care Products
  • It is unclear whether Congress and the President will come to agreement and move forward this year on cosmetics and personal care products legislation.
  • Rather, activity this year may lay the groundwork for action by the next Congress in 2017.
Continue Reading →

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ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.