Conducting a Clinical Investigation

• Clinical Trials
  FDA's Office of Science & Research
• Clinical Trials Guidance Documents
• Clinical Trials Guidance Documents
• Section 8200: Investigational New Drugs (INDs)
  Standard Operating Policies & Procedures (CBER)
• Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications
  A research study funded by the FDA Office of Women's Health
• Clinical Hold / Refusal to File Meetings
• FDA 101: Clinical Trials and Institutional Review Boards
  For Consumers

Compliance, Enforcement, Investigations

• Compliance Actions (Biologics)
• CDER - Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters
• CDER - Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters
• Letters to Industry / Healthcare Providers / Clinical Investigators

Rules

• Expanded Access to Investigational Drugs for Treatment Use, Final Rule (Federal Register)
• Charging for Investigational Drugs Under an Investigational New Drug Application, Final Rule (Federal Register)

Contact FDA