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Fredric Roth V

Associate

Chicago
312 580 5060 direct

Fred counsels clients in the life science and technology industries on a broad range of FDA and USDA regulatory compliance, data privacy and breach response matters and related life science litigation.

Fred analyzes and drafts food labels, FDA regulatory filings for food, drug, device and dietary supplement companies, and assists with product tracking and tracing issues. Fred helps his clients identify and address vulnerabilities in computer hardware and software that may allow unauthorized access to data or device functionality and ensure cybersecurity controls comply with FDA rules.

He also drafts HACCP and HARPC food safety plans for clients as well as advising clients on FDA industry complaints. He has drafted and counseled clients on the filing of 510(k) Premarket Notifications, correct device classifications and compliance with General and Special Controls related to those devices. He has assisted in counseling a variety of food and dietary supplement clients on issues related to labeling, compliance with new nutrition panel requirements and for certain drug clients, on compliance with the Compounding Quality Act. He has also assisted a large multinational chemical and food-ingredient manufacturer as to appropriate registration of foreign suppliers as well as assisted in filing and Industry Complaint with the FDA.

In addition, Fred has assisted life science clients on intellectual property matters including advising on the interplay between their intellectual property and federal regulatory filings as well as in related litigation matters. In addition Fred has represented clients in products liability litigation involving FDA regulated products including, drafting and arguing dispositive motions; working with opposing counsel and state and federal judges; and navigating simple and complex litigation matters.

His scientific background includes advanced training and classes in evolutionary, behavioral and population biology, medical microbiology, chemistry and scientific research as part of his Bachelor's and Master's degrees.

TCLEs

Mobile Medical Apps and FDA’s New Cybersecurity Guidance: It’s a New World

Blogs

11th Circuit better defines FTC’s ‘Unfair’ standard – The details are in the damage

Election results widen gulf between federal v. state regulation of cannabis

The new look of FDA food facility registration: Human and animal food companies beware

Don’t doubt the data breach: Massive Yahoo hack reminds us it’s not if, but when

The silver lining in the DEA’s refusal to reclassify cannabis

The updated face of food labels: The nutrition facts panel

Is encryption the key to your data security?

Protecting food industry whistleblowers: FDA, OSHA team up under FSMA

Food transporters take notice – the FDA’s new Sanitary Transport Rule may affect you

How the FDA’s new Sanitary Transport Rule affects food shipping

Publications

"How Does This Work? Using Mobile Health Technology While Protecting Your Privacy," editor/contributor,
American Health Lawyers Association, September 2016

"The FDA’s Risk-Based Approach To Medical App Enforcement";
Law360, September 2015

"Managing the Changing Drug Compounding Regulatory Landscape";
AHLA Connections, October 2014

Presentations

"Animal Health and Veterinary Medicines 101: Primer on the legal and regulatory landscape for medicines and therapeutics for companion animals and livestock";
ACI: Animal Health and Veterinary Drugs and Therapeutics, September 2015