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

Brian P. Waldman

Brian Waldman, Partner at Arent Fox
Brian P. Waldman
Partner
Washington, DC
202.857.8971

Brian P. Waldman is a member of Arent Fox's Executive Committee, co-manager of the firm’s Regulatory Department, and a member of the department’s Food & Drug Group. Brian concentrates his practice in the area of food and drug law and advertising law, counseling clients primarily on pharmaceutical, medical device, food, dietary supplement and cosmetic issues, with particular emphasis on developing effective strategies for introducing new products.

Client Work

Brian advises clients on a broad range of legal and regulatory issues in all phases of a product’s life cycle, including (i) developing appropriate strategies for the introduction of new ingredients and finished products, (ii) coordinating pre-market safety, efficacy, and claims evaluations, (iii) preparing FDA-related applications and notifications, (iv) designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials, (v) ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion, and (vi) responding to threatened enforcement action. He has counseled clients in all stages of product development, from pre-clinical trials through post-marketing studies. As part of this work, Brian has coordinated interactions between product developers, contract research organizations, site management organizations, institutional review boards, investigators, and the FDA.

Much of Brian’s practice involves crisis management support. Brian assists clients in preparing for and during government investigations, as well as in evaluating and responding to adverse product information. He has coordinated numerous recalls, market withdrawals, and other product corrective actions.

Brian conducts regulatory compliance audits to ensure that both product manufacturers and distributors are in full compliance with applicable laws and regulations. Further, he has drafted proposed federal and state legislation in support of the interests of manufacturers and distributors and represented these interests before legislators and regulators.

Brian works extensively with attorneys in the firm’s Health Group, Intellectual Property Group, and Corporate Transactional Group. He has negotiated numerous licensing, supply and distribution agreements; conducted numerous due diligence audits of acquisition targets; prepared regulatory compliance opinions in support of public offerings; and supported food and drug-related litigation.

Publications, Presentations and Recognitions

Brian recently co-wrote a chapter on dietary supplements in the Food and Drug Law Institute's “Food and Drug Law and Regulation.” He also co-wrote an article titled “Cosmeceuticals: The Legal Problem and Feasible Solutions,” published in The Food, Drug, Cosmetic, and Medical Device Law Digest. He frequently lectures on food and drug approval and regulatory compliance issues for the Food and Drug Law Institute, the Biotechnology Industry Organization, the Center for Professional Advancement, the American Conference Institute, and other seminar sponsors.

Brian was recognized in the 2014 edition of The Best Lawyers in America.

 

Blog Posts by Brian P. Waldman

Consumer Product Safety
alert
FDA to Begin Posting Adverse Event Report Data for Foods and Cosmetics
On December 7, 2016, the Food and Drug Administration published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements and cosmetics. Until now, such adverse event report data has only been publicly available by submission of a Freedom of Information Act request to the Agency. FDA has stated it is providing adverse event data to increase transparency and improve access to such data for consumers, health care providers, researchers, and academics.

Continue Reading →
Consumer Product Safety
alert
FDA Enforcement Against Cosmetics Continues at Record Pace in 2016
  • FDA has issued a record high 19 Warning Letters to cosmetics/personal care product companies in 2016.
  • Companies should promote cosmetics on the Internet with the understanding that FDA may be actively monitoring company websites.
Continue Reading →
Regulatory, Recall & Prop 65
alert
California Retailers: Use of Thermal Receipt Paper Gets Costly
  • The first NOV involving register receipts was issued by the Center for Environmental Health against a restaurant in Lake Forest 
  • California retailers appear to have two options: post warning signs in the store or switch to electronic receipts or BPA-free paper
Continue Reading →

SUBSCRIBE

Add the Arent Fox Fashion Law blog to your RSS feed reader.

Arent Fox In Your Inbox
To subscribe to Arent Fox Alerts and other news, click here.

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.