FDA Regulatory and Risk Management Counseling

We support our clients as they turn their ideas into marketed products, and beyond.

Our clients have looked to us in connection with:

  • FDA, FTC and HIPAA risks in the development and promotion of mobile medical applications
  • legal review of FDA regulatory submissions and communications involving pharmaceuticals and medical devices
  • clinical trials, including clinical research agreements, protocols, CRO agreements, confidentiality agreements and informed consents
  • GLP, GMP and quality systems compliance, and CAPA
  • FDA Warning Letters and inspections
  • FDA advisory committees
  • safety monitoring and reporting obligations
  • product labeling
  • REMS programs
  • patient and product registries
  • advertising, marketing and promotion, including compliance with FDA regulations and Good Promotional Practices
  • private payor communications and promotional activity
  • corporate communications and social media
  • sampling plans and policies
  • potential competitive challenges to promotional materials and activities, including Lanham Act challenges
  • false claims made by third parties such as plaintiffs’ lawyers and state agencies
  • crisis management around highly publicized events such as recalls and congressional committees
  • regulatory due diligence for securities offerings, mergers and acquisitions
  • inquiries from the FDA, the Department of Justice, state attorneys general, and foreign regulators
  • implementation of, and compliance audits related to, Corporate Integrity Agreements
  • internal investigations
  • drug and medical device registration and listing
  • immunity for component part suppliers of implantable medical devices under the Biomaterials Access Insurance Act
  • compliance with the Physician Payments Sunshine Act.

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