Conducting a Clinical Investigation

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

Compliance, Enforcement, Investigations

• Compliance Actions (Biologics)
• Letters to Industry / Healthcare Providers / Clinical Investigators - ARCHIVED

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)