Table 2. FDA Guidance Available for Gene Therapy Products. Only includes regulation and guidance specific to gene therapy products. Reference abbreviation provided is not official nomenclature and is only for the purposes of this review.

Title	Reference (non-official)	Year
Recommendations for Microbial Vectors used for Gene Therapy	FDA-1	2016
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products	FDA-2	2015
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products	FDA-3	2015
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products	FDA-4	2015
Preclinical Assessment of Investigational Cellular and Gene Therapy Products	FDA-5	2013
Potency Tests for Cellular and Gene Therapy Products	FDA-6	2011
Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)	FDA-6	2008
Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors	FDA-7	2006
Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events	FDA-8	2006
Guidance for Human Somatic Cell Therapy and Gene Therapy (superseded by 2013 guidance)	FDA-9	1998