FDA Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors

Investigator-Initiated Investigational New Drug (IND) Applications 

Information for investigators about submitting Investigational New Drug (IND) applications to FDA 1. 
Information for investigators about submitting Investigational New Drug (IND) applications to FDA 2.  Added 11/22/13.

Recruiting Study Subjects-Information Sheet: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm

Payment to Research Subjects-Information Sheet: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126429.htm 

Drugs and Biologics

Emergency Use of an Investigational Drug or Biologic-Information Sheet:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126491.htm

Treatment Use of Investigational Drugs-Information Sheet:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126495.htm

Subpart B–Labeling Requirements for Prescription Drugs and/or Insulin ((FDA, Code of Federal Regulations, Title 21, Volume 4,Revised as of April 1, 2012)

Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND Added 9/17/13