FDA Product Approval

The development, manufacturing, and marketing of a drug or medical device requires an in-depth understanding of the Food and Drug Administration (FDA) regulatory process, as well as the ability to interact effectively with FDA personnel. Our firm’s attorneys provide comprehensive counseling and advocacy on FDA drug and medical device matters, ranging from preparation of drug applications, product clearance and approval to postmarket requirements, enforcement and compliance issues, and product promotion and advertising issues.

The Kendall Law Firm counsels and assists companies with the preparation and filing of New Drug Applications (505(b)(1) and 505(b)(2)), Abbreviated New Drug Applications (ANDAs) and Investigational New Drug (IND) Applications.

Areas of counsel include:

  • Approval Strategies (from investigational stage through options such as fast track, accelerated approval and treatment INDs)
  • Statutory and Regulatory Standards and Requirements
  • Application Processes
  • FDA/Advisory Committee Meetings
  • Contract Research Organizations (CROs), Clinical Investigators and Data Management Organization Arrangements
  • Institutional Review Board (IRB) and Data Safety Monitoring Board (DSMB) Issues
  • Post-approval Support
  • Risk Mitigation Strategies
  • Reimbursement Strategies and Market Exclusivity
  • Adversarial matters such as civil penalty proceedings, criminal prosecutions, injunctions, product seizures, expert witness assistance, Lanham Act issues

 

The Kendall Law Firm also counsels and assists with the preparation and filing of Investigational Device Exemption (IDE) applications, Premarket Approval Applications (PMAs) and Premarket Notification Submissions 510(k)(s).

Areas of counsel include:

  • Approval Strategies (from investigational stage through approval preparation including dossier development and determination of whether premarket approval is necessary)
  • Statutory and Regulatory Standards and Requirements
  • Application Processes
  • Classification and Reclassification of Medical Devices
  • Quality Systems Requirements and Reporting
  • FDA/Advisory Committee Meetings
  • Risk Assessment and Preventative Counseling
  • Reimbursement Issues
  • Risk Mitigation Strategies
  • Adversarial matters such as civil penalty proceedings, criminal prosecutions, injunctions, product seizures, expert witness assistance, Lanham Act issues