Food, Drug, Medical Device & Cosmetic
Our work includes developing strategies for introducing new products and technologies, interacting with FDA and the US Drug Enforcement Agency over approvals or clearances necessary for the products and technologies to go to market, coordinating promotional activities and post-marketing compliance with adverse event reporting, auditing manufacturing and distribution plants for compliance with FDA regulations, assisting with FDA inspections and responses, as well as recalls and market withdrawals; participating in legislative and regulatory advocacy; initiating and defending product challenges; and advising on the acquisition and sale of products and companies.
Our Food, Drug, Medical Device & Cosmetic team is currently working hand-in-hand with numerous other practices in the firm to help our clients address novel COVID-19 issues. Click here for more information.
Our lawyers and regulatory and scientific professionals partner with our clients every step of the way to navigate the legal and regulatory requirements enforced by the FDA, DEA, US Department of Agriculture, US Environmental Protection Agency, Federal Trade Commission, Consumer Product Safety Commission, and their state counterparts, as well as US Customs and Border Protection.
ArentFox Schiff has one of the leading Food, Drug, Medical Device & Cosmetic practices in the country. The team includes former attorneys with FDA, EPA, and CBP, a bio-organic chemical scientist, and former trade association counsel. With this comprehensive array of backgrounds and industry expertise, we provide regulatory counseling for manufacturers, distributors, retailers, and trade associations from every sector that is regulated by FDA.
Sectors We Help
Our clients rely on us with their product development and growth strategies. We counsel start-ups, Fortune 500 companies, domestic and foreign manufacturers, distributors, and retailers, leading industry trade associations, and private equity funds through every facet of their business cycle.
What We Do
- Develop strategies to introduce new products and maximize product life cycle
- Coordinate SOPs for manufacturing and promotional compliance
- Prepare clients for government inspections and respond to inspectional observations
- Coordinate ingredient/product safety reviews and claim substantiation reviews
- Counsel on labeling and advertising requirements
- Coordinate responses to receipt of adverse product information and, as applicable, investigation and implementation of product recalls, market withdrawals, and stock recoveries
- Defend companies during regulatory and criminal investigations
- Advise on import and export issues, securing product release and market entry into new markets
- Handle all potential transactional matters, from mergers and acquisitions to licensing/distribution/contract manufacturing/supply deals, to due diligence
- Advocate for legislative and regulatory change
Our Food, Drug, Medical Device & Cosmetic attorneys work closely with skilled attorneys in many other practice areas to advise clients on matters where multiple areas of law intersect. We draw on the in-depth knowledge of ArentFox Schiff’s Health Care, Patent, Trademark, Privacy, International Trade, Proposition 65, and Cannabis lawyers to help clients achieve desired outcomes on complex litigation, business, and regulatory matters, including Medicare and Medicaid concerns, trademark protection, patent application and defense, product coverage and payment, privacy issues, import-export matters, and regulatory issues involving the production and sale of cannabis and hemp.