Cancer Drug and Biological Products - Clinical Data in Marketing Applications
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
October 11, 2001
April 30, 2020
46d12435-8972-4d63-a8eb-3c3d753c0178
Related Documents
M4S: The CTD -- Safety Appendices
Guidance DocumentAugust 1, 2001Center for Drug Evaluation and Research
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information: Guidance for Industry
Guidance DocumentMay 1, 2001Center for Drug Evaluation and Research
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer: Guidance for Industry
Guidance DocumentJanuary 15, 2004Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.