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.
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:
Treatment Use of Investigational Drugs-Information Sheet:
Subpart B–Labeling Requirements for Prescription Drugs and/or Insulin ((FDA, Code of Federal Regulations, Title 21, Volume 4,Revised as of April 1, 2020)
Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND Updated 11/18/2020