Burns & Levinson has unique experience with products regulated under the Federal Food, Drug, and Cosmetic Act, the Hatch-Waxman Act, the Federal Trade Commission Act, the Lanham Act, the Consumer Product Safety Act, the Public Health Service Act, and other federal and state laws.
Clients from large multi-national corporations to emerging growth and startup organizations come to us for help navigating regulatory requirements for pharmaceuticals, biologics, medical devices, foods, dietary supplements, cosmetics and nonprescription drugs. Our team also has the experience you need to handle regulatory issues during drug and device development, from pre-clinical development to clinical trials, through the FDA review process and post-market requirements. The team’s special experience includes intellectual property attorneys who have backgrounds as registered pharmacists, FDA regulators, chemists and scientists.
Local and international companies that are subject to the FDA and its foreign counterpart turn to Burns & Levinson’s Food and Drug Law practice for assistance with:
- Early-stage regulatory strategy
- Product development and clinical trial issues
- Submissions to the FDA
- Marketing compliance and enforcement matters
- Counseling on FDA, FTC, DEA, and healthcare compliance issues
- Manufacturing and supply-chain management
- Defense in civil and criminal government investigations
- Investigational new drug applications (INDs) to conduct research to support applications for regulatory approval in the United States; new drug applications (NDAs) for initial approval of drug products in the U.S., and abbreviated new drug applications (ANDAs) for approval of generic drugs in the U.S.
- Analyze legal and policy issues surrounding the Hatch-Waxman Act and the patent certification implications for ANDAs, and Section 505(b)(2) applications.
- Develop regulatory strategies for the commercialization of new drugs and the impacts of different non-patent market exclusivity periods.
- Help companies comply with import/export regulatory requirements.
- Assist in determining the status of over the counter drugs and compliance with applicable monographs.
- Evaluate compliance with and amending USP/NF, EP, and other national pharmacopoeia monographs; preparing and filing Drug Master Files (for active ingredients, inactives, and packaging components).
- Advise on compliance issues, including current good manufacturing practice (cGMP) requirements, labeling and advertising issues involving traditional media and social media, conducting product recalls, U.S. FDA inspection practices, and defending against government enforcement actions.
Medical Device Law
- Advise on the need to submit and, if necessary, prepare premarket notifications (510(k)s), applications or Premarket Approval applications (PMAs) in the U.S.; and related international applications, such as CE marking.
- Assist in establishing compliance with the essential requirements of the Medical Devices Directive and with similar international requirements.
- Advise on the proper classification of devices.
- Assist with additional compliance issues, including good manufacturing practice/quality system (QS) regulation matters; establishment registration and device listing; product recalls or market withdrawals; Medical Device Reports (MDRs) (Part 803) and Reports of Corrections and Removals (Part 806); U.S. FDA inspection practices; responding to warning letters and other actual or threatened enforcement actions; and advising on device promotion and advertising boundaries.
- Review labeling and advertising for compliance with U.S., EU, and related international requirements.
- Advise on the classification of a product as a cosmetic or a drug based on the product claims.
- Providing guidance on the safety testing of cosmetic ingredients, including toxicology, carcinogenicity, and sensitivity testing on volunteers.
- Assisting in compliance issues, including good manufacturing practices, recordkeeping, product recalls, and governmental inspection practices.
- Defending against FTC advertising complaints, enforcement actions and prosecutions, and defending against competitor challenges in court and other forums.
- Management of product recalls.
- Provide opinion letters on the compliance status of food ingredients and additives, functional foods, and substances used in food packaging and processing equipment.
- Assist in establishing "Generally Recognized as Safe" status for novel food ingredients and food packaging materials used in the U.S., and in assembling appropriate documentation to support a safety evaluation for food contact materials used in the EU.
- Advise on food labeling, allergen labeling, and advertising issues, including criteria for making "nutrition," "health," and "structure/function" claims.
- Assist with compliance issues, including good manufacturing practice requirements, product recalls, U.S. FDA inspection practices and warning letters, and record keeping and traceability requirements.
- Monitor legislation and policies affecting the regulation of food additives, ingredients, and materials used in contact with food, and providing strategic analysis of relevant laws and treaties, including proper application of the principle of mutual recognition in the EU.
Dietary Supplement Law
- Review labels, labeling, and advertising for compliance issues.
- Advise dietary supplement manufacturers and distributors regarding claims (and the substantiation needed to support them) that may appear in advertising, labeling, and promotional materials for these products, including the claims used to market dietary supplements via the internet.