FDA Policies and Publications Related to Cancer

Accelerated Approval (Subpart H)
Access to Unapproved Drugs
Adverse Event Reporting and Risk Assessment
Advisory Committee
Cancer Patient Programs at the FDA
Clinical Trial Listings
Code of Federal Regulations
Conducting Clinical Studies-General Guidances and Resources
Dictionary of Regulatory Terms
Fast Track
FDA Cancer Approval Process and Guidances
FDA Cancer Initiatives
FDA Forms
FDA Guidances Indexed by Center
FDA Public Notices, Documents and the Federal Register
FDA Structure and Responsibilities
Food Drug and Cosmetic Act
How to file for a New Drug Application (NDA)
How to file for a standard Investigational New Drug (IND)
How to file for an emergency Investigational New Drug (IND)
Importing & Exporting Medications
Institutional Review Boards
Non-clinical studies and chemistry
Orphan Drugs and the Orphan Drug Program
Overview of Therapeutic Development
Priority Review
Regulatory Agencies
Special Populations