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Health Care Law: Pharmaceuticals

Health Care Law: Pharmaceuticals

Our experienced attorneys and advisors assist drug manufacturers through the constant evolution of complex legislative, regulatory, and marketplace demands on the pharmaceutical industry. We work closely with our clients to ensure that their legislative and  regulatory strategies are directed toward maximizing opportunities and securing compliance with federal and state laws and regulations. Our services include:

  • Legal and regulatory research, analysis, and counsel on local, state, and federal statutes, rules, and regulations, including
    • Biologics Price Competition and Innovation Act (BPCIA)
    • Controlled Substances Act (CSA)
    • Drug Addiction Treatment Act of 2000 (DATA 2000)
    • Food and Drug Administration Amendments Act (FDAAA)
    • Food, Drug and Cosmetic Act (FDCA)
    • Patient Protection and Affordable Care Act (ACA)
    • Prescription Drug User Fee Act (PDUFA),
    • Public Health Services Act
  • Strategies to address the counterfeiting and illicit market of pharmaceuticals
  • Counsel on product development, labelling,¬†distribution, dispensing, and disposal
  • Risk management and prevention of prescription drug, diversion, and abuse
  • Preparation and assessment of Risk Evaluation and Mitigation Strategies (REMS)
  • Drafting of citizen petitions and amicus briefs
  • Participation on advisory boards