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In Brief: A Digest of Federal Regulatory Projects

 

Related Industries:

Food & Agribusiness Life Sciences
 
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.