EXPERIENCED COUNSEL

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.