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Phase 1 IND Procedures and Policies

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Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures used by staff in FDA’s Center for Drug Evaluation and Research (CDER). MAPPs are required by law and made available to the public to make CDER a more transparent organization.

Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates.

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TitleDate Posted/Effective DateTopicsSummaryApplies to
MAPP 5100.3: OCP Prioritization, Triage, and Review Process for INDs and Pre-INDsMarch 3, 2023Clinical pharmacology IND review triageExplains how OCP prioritizes and documents clinical pharmacology input for pre-INDs and IND submissions.CDER
MAPP 6030.9: Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and ReviewApril 29, 2013IND review managementEstablishes CDER principles for timely, consistent management of IND submissions.CDER
MAPP 6025.6 Rev.1: Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics February 28, 2024Breakthrough therapy developmentGuides enhanced FDA–sponsor interactions and timelines for breakthrough-designated IND programs.CDER
MAPP 6020.5 Rev. 2: Good Review Practice: OND Review Management of INDs and Marketing Applications for Nonprescription Drug Products  June 25, 2018Nonprescription IND/NDA reviewApplies OND review-management practices to INDs supporting nonprescription drug development.CDER
MAPP 5210.9 Rev. 1: Review of Botanical Drug ProductsJanuary 21, 2022Botanical drug reviewDefines review process and team roles for botanical IND submissions.CDER
MAPP 6030.2 Rev. 2: INDs: Review of Informed Consent Documents July 17, 2025Informed consent reviewHelps assess adequacy of informed consent for IND clinical investigations.CDER
MAPP 6030.1 Rev. 3: IND Clinical HoldsFebruary 20, 2018IND clinical holdsDefines procedures for issuing, overseeing, and responding to clinical holds on IND trials.CDER
MAPP 5015.13 Rev.1: Quality Assessment for Products in Expedited ProgramsJuly 31, 2025Expedited quality assessmentAddresses OPQ quality assessment for expedited programs, including INDs and CMC considerations.CDER
MAPP 5310.3 Rev. 2: Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls ChangesDecember 19, 2024Expedited CMC supplementsPrimarily post-approval; informs IND strategy via understanding expedited CMC pathways.CDER
MAPP 5310.7 Rev. 1: Acceptability of Standards from Alternative Compendia (BP/EP/JP) September 18, 2024BP/EP/JP standardsClarifies use of non-USP compendial standards in IND CMC specifications.CDER
MAPP 5015.12: Process for Evaluating Emerging Technologies Related to Quality November 29, 2022Emerging manufacturing technologiesSupports early FDA engagement on novel manufacturing approaches used in INDs.CDER
MAPP 5015.5 Rev. 1: CMC Reviews of Type III DMFs for Packaging MaterialsDecember 9, 2022Packaging DMF CMC reviewGuides assessment of packaging DMFs referenced in IND submissions.CDER
MAPP 5015.7 Rev. 1: Environmental Assessments and Claims of Categorical ExclusionNovember 23, 2022Environmental assessmentsExplains review responsibilities for environmental considerations in INDs.CDER
MAPP 5021.2: Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAsJune 3, 2021Color additives, flavorsGuides evaluation of excipients (colors/flavors) in IND CMC submissions.CDER
SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug ApplicationsJanuary 14, 2026IND processing and reviewInstructing on how to process and review IND under CBER policiesCBER
SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug ApplicationsJanuary 14, 2026Clinical holdsInstructing how to place and remove IND on/from a clinical holdCBER
SOPP 8203: Evaluation of Cost Recovery Requests for Investigational New Drugs and Investigational Device ExemptionsDecember 11, 2020Cost recoveryExplains how to process sponsor’s request to recover costsCBER
SOPP 8212: Breakthrough Therapy Products - Designation and ManagementApril 8, 2026Breakthrough therapy products managementInstructs how to expedite the development of a breakthrough therapy consistent with the existing policiesCBER
SOPP 8215: Management of Regenerative Medicine Advanced Therapy Products: Request for Designation, Sponsor Interactions, and Status AssessmentMarch 12, 2026Regenerative medicine managementInstructs how to process requests for regenerative medicine advanced therapiesCBER
SOPP 8216: Fast Track Development Programs - Designation and ManagementApril 8, 2026Fast track designation managementInstructions on processing and reviewing requests for fast-track designationCBER
SOPP 8301: Receipt and Processing of Master FilesMay 7, 2026Master files managementInstructions on administrative processing and review of Master FilesCBER
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