In Brief: A Digest of Federal Regulatory Projects

Client Success

Counsel clients on national and international life sciences regulatory matters, including FDA and FTC issues.
Obtained FDA 510(k) clearance for medical devices, including certain nonvascular interventional stenting products in the portfolio of a medical systems company.
Implemented strategy with FDA that resulted in the lifting of a warning letter, allowing a leading medical-technology manufacturer to get new products to market.
Filed Food Additive Petitions for animal feed products.
Counseled dietary supplement clients on labeling compliance and permissible marketing claims.
Represented numerous food and dietary supplement companies on recalls.
Filed Investigational New Drug Applications, drafted clinical trial agreements and subsequently filed New Drug Applications for numerous novel human drugs.
Represented clients in civil investigations and disputes with the FDA and FTC, including but not limited to fraud and marketing claims.
Counsel clients regarding FDA marketing exclusivities arising out of ANDA patent litigation.
Represented company’s chief executive officer in FTC investigation alleging $100 million fraud.
Represented a variety of individuals and entities in investigations involving DEA diversion.
Counsel clients on DEA licensing/registration issues
Defended pharmaceutical manufacturer in a criminal FDA investigation regarding quality controls, validation of manufacturing protocols and timeliness and accuracy of field alert submissions.
Negotiated numerous clinical trial agreements for large, multisite clinical trials.
Counsel food clients on compliance with the Food Safety and Modernization Act, including assisting in drafting the required plan and related documents.
Counsel clients on FDA detention and seizure issues and response to same.
Counsel animal health companies on feed additives, animal drug development processes, achieving MUMS designation and developing of protocols for pivotal field studies
Counsel animal food companies and pet supply companies on recalls when tainted feed is suspected or confirmed.
Counsel clients on FTC and FDA investigations into misbranding, adulterated products and mislabeling and marketing claims.
Acted as regulatory counsel to animal health products when drafting securities filings for purposes of going public.
Advised clients on compliance with Good Manufacturing Practices and negotiated and drafted manufacturing agreements.
Advised food clients concerning labeling issues for cheese products
Advised meat-packing clients on inspection issues arising from certain packing and processing practices
Advised clients on FDA’s detention practices for imports.