FDA & Life Sciences

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Hall Render attorneys have experience advising clients in various areas of pharmaceutical, medical device, biotechnology and life sciences research law. We have handled a broad spectrum of matters for our clients, including regulatory compliance, governmental investigations and defense, conducting clinical trials, product liability defense, intellectual property, labor and employment and business transactions. Our experience in...Read More

Hall Render attorneys have experience advising clients in various areas of pharmaceutical, medical device, biotechnology and life sciences research law. We have handled a broad spectrum of matters for our clients, including regulatory compliance, governmental investigations and defense, conducting clinical trials, product liability defense, intellectual property, labor and employment and business transactions. Our experience in the many areas of law impacting the life sciences industry allows us to provide prompt, effective counsel to our clients. We have also assisted clients with related areas, such as advertising medical products and pharmaceutical trade.

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Areas of Focus

  • Administrative Matters
    • Advice on health care products advertising
    • Assistance with regulatory inspections and corrective action responses
    • Counsel regarding pricing issues
    • Facilitation of effective communications with agencies, authorities and legislative bodies
  • Clinical Research
    • Clinical Trial Agreements
    • Creation, organization and improvement of research programs
    • Good clinical practice methods
    • Institutional Review Board issues
    • Preserving integrity in research
  • Governmental Regulation
    • False Claims Act counsel
    • Federal and state anti-kickback and fraud and abuse laws
    • Federal and state self-referral laws, including the federal Stark law
    • Federal, state and international privacy laws, including HIPAA and the EU Privacy Directives
    • Food and Drug Administration regulations
    • Research Misconduct Investigations
    • The Common Rule
  • Intellectual Property and Technology
    • Compliance
    • Data transfer and privacy issues
    • Intellectual property and technology transfer
    • Licensing
  • Pharmaceuticals and Medical Devices
    • Advice on the marketing and distribution of pharmaceutical products
    • Advice on trade/sale of pharmaceutical products
    • Advice regarding intellectual property and technology transfer issues for pharmaceutical products and medical devices
    • Legal monitoring of the development of new pharmaceutical products and medical devices