Regulatory

Is your product regulated by the FDA?

• Regulatory Resources for Drugs
  Center for Drug Evaluation and Research
  Drug Development Resources (FDA)
  IND Overview and IND Application Process

• Regulatory Resources for Devices and Radiological Health
  Center for Devices and Radiological Health
  Overview of Device Regulation
  Medical Device Product Classification Searchable Database (FDA)
  IDE Overview and IDE Application Process
  PMA Application Process

• Regulatory Resources for Biologics
  Center for Biologics Evaluation and Research
  IND Overview and IND Application Process

• Regulatory Affairs in the News
  Regulatory Affairs Professional Society
  World Pharma News
  FDA News