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. Author manuscript; available in PMC: 2019 Jul 23.
Published in final edited form as: Ann N Y Acad Sci. 2010 Nov;1212(Suppl 1):E1–14. doi: 10.1111/j.1749-6632.2010.05839.x

Table 1.

Regulatory information for probiotics studied as investigational new drugs

Ask CBER/FDA if an IND application is needed
 Center for Biologies Evaluation and Research
 Office of Communication, Training and Manufacturers Assistance
 Manufacturers Assistance and Technical Training Branch
 800-835-4709 or 301-827-1800
 matt@cber.fda.gov
Comply with current good manufacturing practices
 “Current Good Manufacturing Practice Regulation and Investigational New Drugs”
 Draft guidance, “INDs—Approaches to Complying with CGMP During Phase 1”
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064971.htm
Request a pre-IND meeting
 “Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products”
 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079744.pdf
Describe probiotic test product
 “Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description for Vaccine or Related Product”
  http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucmO76612.htm
 “Guidelines for Drug Master Files”
 http://www.fda.gov/cder/guidance/dmf.htm
Learn from other’s related experience
 Shapiro, S. Z. 2002. The HIV/AIDS vaccine researchers’ orientation to the process of preparing a USFDA application for an investigational new drug (IND): what it is all about and how you start by preparing for your pre-IND meeting. Vaccine 20: 1261–1280.