Food, Drug, and Life Sciences Practice Group

Fuerst, Ittleman, David, and Joseph’s food, drug and life sciences practice group is adept at addressing the specialized needs of clients doing business in FDA-regulated industries. Our attorneys are sensitive to the unique regulatory and business needs of clients who manufacture and distribute a host of FDA-regulated products, including foods, drugs, medical devices, supplements and medical foods, among others. From initial product ideation to raising investor capital through marketing and distribution, clients must balance their business strategies and risks with the legal and regulatory requirements imposed by state and federal governments. Fuerst, Ittleman, David, and Joseph is well-equipped to help clients achieve their business goals while maintaining regulatory compliance with the appropriate regulatory agencies, including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and state and local agencies.

Our food, drug, and life sciences practice group services and the industries we serve include:

Industries Served
Animal and Veterinary Products
  • Devices
  • Drugs
  • Pet food and animal feed
Food and Drug Industries
  • Cosmetics
  • Dietary supplements
  • Foods and beverages
  • Medical foods
  • OTC drugs
  • Homeopathic drugs

 

Medical Tourism

Combination Products

Life Sciences
  • Medical devices
  • Prescription pharmaceuticals
  • OTC drugs
  • Homeopathic drugs
  • Stem cells and regenerative medicine
  • Clinical researchers

Legal Services 
Advertising and Consumer Law
  • FTC advertising compliance
  • FDA labeling and marketing compliance
  • FTC and FDA litigation
Agency Enforcement Actions and Litigation
  • FDA Warning Letters
  • FDA inspections and 483s
  • USDA inspections
  • FDA, FTC, USDA litigation
  • Product recalls and injunctions
Animal and Veterinary Products
  • Animal drugs
  • Devices
  • Marketing and labeling
  • Minor species products
  • Pet food and animal feed
Biologics and HCT/Ps
  • BLA Applications
  • FDA Warning Letters, Untitled Letters, and other enforcement actions
  • Litigation
  • cGMPS and GCPs
  • FDA registration
  • Import and export
  • Clinical research and IRB oversight
Corporate Services
  • Retail and distribution agreements
  • Transactional matters
  • Insurance policy reviews
  • Partnership and corporate agreements

 

Cosmetics
  • FDA labeling compliance
  • Ingredient review
  • Color additives
  • Claims and marketing
 Drugs
  • OTC monographs
  • Homeopathic monographs
  • Registration and listing
  • Competitor market discipline
  • cGMPs
Food, Beverages and Supplements
  • FDA labeling compliance
  • Claims review
  • cGMP compliance
  • Ingredient reviews
  • GRAS and new dietary ingredients
  • Organic and natural claims
  • USDA compliance
  • Registration
  • Medical foods
Import/Export
  • Import for Export program
  • FDA Import Alerts
  • CBP Notices to Mark and/or Redeliver
  • FDA detentions and refusals
  • FDA import and export compliance
  • USDA certifications
Medical Devices
  • 510(k)s and PMAs
  • De novo process and IDEs
  • Product classification
  • Agency dispute resolution
  • Labeling and marketing
  • Registration and listing
  • QS/cGMPs
Medical Tourism
  • Advertising and marketing
  • FDA and FTC compliance
  • Corporate structure and tax compliance