Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry. If, after cancellation of the pre-IND meeting, the sponsor subsequently wishes to follow-up on topics from the preliminary responses or pose new questions, then the sponsor should submit these follow-up or new questions in the original IND. The sponsor may submit their version of the minutes to the file to summarize their understanding of issues discussed at the meeting. Is the assay qualification plan sufficient? For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the meeting request. If questions are too broad or general, OTATs response may also be general. Not for implementation. Brief discussion of the manufacturing facility, and steps taken to ensure product segregation and tracking. )U!$5X3/9 ($5j%V*'&*r" (,!!0b;C2( I8/
Sponsors should follow the timelines for meeting package submission, as described in the Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry and indicated above in theTable. %%EOF
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However, as denoted in the table below, by Day 21, OTAT will send the decision to grant or deny the meeting request, along with the meeting date, if granted, or reasons for denial. Post-meeting follow-up (teleconference vs. WRO). ****For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the meeting request. If unable to submit comments online, please mail written comments to: Dockets Management Questions regarding products other than the product that is the subject of the meeting. **Calendar days from FDA receipt of the meeting request to the date that OTAT will respond with the decision to grant or deny the meeting, as well as specifying the format and date of the meeting, if granted. Pre-IND meetings can be valuable for sponsors in procuring feedback on a sponsors product development program, especially if a sponsors questions are not fully answered by guidance documents and other publicly available resources. Does the FDA agree that the testing and characterization of the cell banks are adequate?
OTAT will not commit to reviewing packages greater than 250-300 pages or answering questions that require review of this much material. The .gov means its official.Federal government websites often end in .gov or .mil. Instead, the meeting requestor may consider submitting the product manufacturing information in a Master File (MF) to OTAT so that IND sponsors using the product can crossreference the MF. The .gov means its official.Federal government websites often end in .gov or .mil. Number of questions. Will vector shedding studies be required? The previous guidance for industry entitled Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants, issued on November 18, 2015, has been withdrawn. See INTERACT Meeting Section for information regarding INTERACT meetings. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). However, because OTAT staff will be familiar with the meeting package content and questions, OTAT recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTATs preliminary responses to the sponsors questions. The pre-IND meeting will be scheduled to occur within 60 days of receipt of the meeting request. Examples of reasons for denial are included below: The sponsors meeting package should include a limited number of clearly worded and targeted questions that directly address concerns about the product development programs. After receiving OTATs preliminary response, the sponsor. The sponsor may submit their version of the meeting minutes to the file to summarize their understanding of issues discussed at the meeting. Meeting packages are typically 50 100 pages. Written Response Only (WRO) is considered to be equivalent to 60 minute meetings. Such new questions/alternative approaches should be submitted as part of the original IND. Does the FDA agree that the data from the completed in vitro and in vivo proofof-concept (POC) studies are acceptable to initiate the proposed clinical trial? After receiving OTATs preliminary response, the sponsor. endstream endobj 533 0 obj <>stream In some situations, a sponsor may want to develop new questions/alternative approaches in response to OTATs preliminary responses or discussion at the meeting. A cover letter should be included in the briefing package with the inclusion of the assigned PTS number. A pre-IND meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold. Before sharing sensitive information, make sure you're on a federal government site. HWn8}WQ^uYtS^'m3h_I8b("^unj|,MaIwz?H*)8xOA,JK7CI8m?I ~WTU8e8&QbjvQ.bMSUXBc+ye&@d-h,418i#x./d&G#.FF\aq [3v6811Jl3%%J9I3zvO",I[7C" The format for pre-IND meetings is typically either a teleconference or Written Response Only (WRO). All written comments should be identified with this document's docket number: FDA-2018-D-1922. The meeting also provides an opportunity to discuss the plans for studying the product in pediatric populations, the target product profile, the quality target product profile, the design and results of any natural history studies, and the best approach for presentation and formatting of data in the IND.
The subject line of the email should include the assigned PTS number and meeting briefing package. The meeting request does not include specific questions or the questions are not appropriate for a pre-IND meeting. Whether the sponsor had a prior pre-IND meeting with OTAT for the same or similar product or indication. Therefore, attempts to separate meetings into discipline-specific discussions can lead to inadvertent miscommunication and duplication of effort. The OTAT responses can be interpreted ambiguously and are unclear to the sponsor (e.g., Did you mean A or B?), Questions related to new information not included in the briefing package, Questions related to the adequacy of new proposals to address OTAT comments [e.g., new clinical trial designs, study endpoints, new patient population, new/modified assays, new preclinical study design, new materials (i.e., raw materials, source materials)]. As stated above, during the meeting the OTAT team will not be able to provide feedback on new information (e.g., new questions, alternative approaches or new proposals to address OTAT comments) that was not previously submitted in the original briefing package. However, OTAT may not review such submissions; therefore, the absence of an OTAT response to such submissions does not imply OTAT concurrence with the sponsors version of the minutes. Sponsors should pose clear, focused questions so that OTAT can provide advice targeted to the specific product development program. *** Calendar days from FDA receipt of the meeting request to date the meeting will be held, or the WRO will be issued. Cellular & Gene Therapy Products, Recalls, Market Withdrawals and Safety Alerts, Approved Cellular and Gene Therapy Products, Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry, Determining pre-IND meeting format (e.g., Written Response Only (WRO) vs. teleconference), Common reasons for denial of a pre-IND meeting request, SOPP 8301: Receipt and Processing of Master Files, Examples of pre-IND meeting package content (CMC, P/T, clinical), Examples of questions appropriate for a pre-IND meeting (CMC, P/T, clinical), Examples of questions that are not appropriate for a pre-IND meeting, Best Practices for Managing Pre-IND Meetings with OTAT, At least 30 days before the scheduled date of the meeting or WRO. endstream endobj startxref Is the delivery device compatibility plan sufficient? OTAT will not provide the sponsor with minutes for such informal teleconference. hbbd``b`:$W@HuYw0 B Not for implementation. hbbd``b`k`;$A\ Z r_O r Table: Timelines for Pre-IND (Type B) Meetings. OTAT recommends that time be reserved at the end of the meeting for the sponsor to summarize the major discussion points and action items. 134 0 obj <>stream 0 Is the study population, as described in the enrollment criteria, appropriate for the proposed first-in-human (FIH) study? To ensure that the appropriate FDA staff are assigned to the meeting, the meeting request should include draft questions. 1919 0 obj <>/Filter/FlateDecode/ID[<5C91AEC681E59649AA1ED405CB3BC087><3D2E9DFB47A6E641ADD5CAC9246F5847>]/Index[1901 47]/Info 1900 0 R/Length 88/Prev 317242/Root 1902 0 R/Size 1948/Type/XRef/W[1 2 1]>>stream Draft questions submitted in the meeting request can be refined with the submission of the meeting package. All written comments should be identified with this document's docket number: FDA-2022-D-0080. If the sponsor finds that OTATs preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTAT in writing as soon as possible so that OTAT may cancel the meeting. As a rule, the meeting discussion follows the prioritized order of importance set by the sponsor, with the understanding that all questions may not be addressed due to time constraints. kLa2\p.>:o'? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Description of the product, manufacturing process and testing conducted (inprocess / final product) to demonstrate product identity, quality, and safety, Description of product formulation and storage conditions, Detailed descriptions of any CMC issues on which feedback is being requested (e.g., sourcing of starting materials, potency assessment). Written Response Only (WRO) is considered to be equivalent to 60-minute meetings. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester (s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or written response only (WRO)). HUnFCmzx8 _z.IOMf@z^n$`Y0 B$" !c/'*STk>a" abP`~h. (*(%8H8c- fd9@6_IjH9(3=DR1%? The meeting request is substantially incomplete based on the omission of one or more of the elements identified in the. 0
The sponsor should provide a clinical trial protocol synopsis or draft protocol that includes, but is not limited to: The maximum number of questions that can be covered in a preIND meeting is 12. In some situations, OTAT may suggest an INTERACT meeting. Sponsors should consider this limitation and identify the most important questions for their specific development program. Are the Dose-Limiting Toxicity criteria acceptable? Does OTAT agree with the approach used to determine the proposed starting dose and dose-escalation plan for the product in the proposed Phase 1 trial? However, because OTAT staff will be familiar with the meeting package content and questions, OTAT recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTATs preliminary responses to the sponsors questions. 1901 0 obj <> endobj Does the FDA agree that the overall preclinical program is adequate, pending the study results, to support the proposed Phase 1 clinical trial? The meeting request should include a list of the specific objectives of the meeting and a list of questions [grouped by discipline, e.g., Chemistry, Manufacturing, and Controls (CMC), pharmacology / toxicology, clinical, statistical]. The clinical assay, xxx, will be used to determine patient eligibility for study enrollment.
109 0 obj <> endobj The sponsor should include their request for clarifications for all disciplines in a single follow-up request. )/q/lkeEWcKaz_7j6}coz+;\gkz"^F6/$oZxmtKT01 ySwxQn@Eq8h|VMxuK0lo>5wv\g5BTpmc/2*N7o4 1"I,j!N G : You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). endstream endobj 529 0 obj <>/Metadata 41 0 R/Outlines 68 0 R/PageLayout/OneColumn/Pages 524 0 R/StructTreeRoot 107 0 R/Type/Catalog>> endobj 530 0 obj <>/Font<>>>/Rotate 0/StructParents 0/Type/Page>> endobj 531 0 obj <>stream Whether the sponsor had a previous or current IND for the same or similar product or indication. OTAT will consider the follow-up request, and if determined to be limited to clarification, OTAT will issue a response in writing within 20 calendar days after receipt of the clarifying questions. Whether the questions are straightforward or complex. Simple requests for clarification of OTAT WRO may be sent to the Regulatory Project Manager (RPM) within 20 days after receipt of the WRO. If the sponsor finds that OTATs preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTAT in writing as soon as possible so that OTAT may cancel the meeting. The number of questions in a meeting package should not exceed what can be reasonably discussed within the duration of the allotted meeting time. in all areas. Description of devices that will be used for product administration or cell selection, A comprehensive discussion regarding the justification for all elements of the preclinical program, A comprehensive summary of all completed preclinical studies (in vitro and in vivo studies, animal species / models, study designs, resulting data and interpretation), Complete protocols for the proposed definitive preclinical safety / toxicology and distribution studies, with sponsors rationale for the respective study design (e.g., animal species/models, dose levels, dosing regimen and procedure, study endpoints, sacrifice intervals), intended patient population (e.g., age, severity of disease, phenotype), delivery procedure, including device (as applicable), Safety and preliminary efficacy endpoints (e.g., outcome measures). 5630 Fishers Lane, Rm 1061 Does the FDA agree with the stability testing of the drug substance and drug product? *** Calendar days from FDA receipt of the meeting request to date the meeting will be held, or the WRO will be issued. An official website of the United States government, : endstream endobj 1 0 obj <>/Font<>>>/Rotate 0/StructParents 1/Type/Page>> endobj 2 0 obj <>stream Sponsors should also refer to available FDA guidances applicable to their product. OTAT schedules Pre-IND meetings for 60 minutes. Rockville, MD 20852. For a 60-minute meeting, a maximum of 12 questions (inclusive of sub-questions) would be considered reasonable. OTAT evaluates each meeting request to determine whether to grant or deny the meeting, and to determine the appropriate format for the meeting. Food and Drug Administration The meeting package for a pre-IND should be submitted no later than 30 days before the scheduled date of the pre-IND meeting or WRO (see Table above). If sponsors disagree with the content of OTATs minutes, OTATs meeting minutes will not be altered except to correct a substantive mistake for the record (on extremely rare occasions). The site is secure. The .gov means its official.Federal government websites often end in .gov or .mil. Source: Tableinformation from the Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry The sponsor has completed proof-of-concept (POC) and possibly some preliminary preclinical safety/toxicology studies and desires to move to the definitive toxicology studies. For example, a question such as whether the overall proposed manufacturing approach or clinical program is adequate for enabling the IND is too broad. Does the FDA agree that the animal species / model evaluated in the POC and toxicology studies is acceptable? Whether the preclinical testing and manufacturing process for the product use the same/similar platform as other product(s) submitted to OTAT by the same sponsor. h_k0`I,JVX:(}$. Contains non-binding recommendations. The academy is established to help players from Ghana and across Africa gain recognition and advance their football careers. If the meeting requestor intends to manufacture and provide their product to other investigators to conduct IND studies, OTAT will not grant a Type B pre-IND meeting to discuss product manufacturing. hb```d @`Q|G= vvm6O?jr|` 3Q@ m=fbBx8n875$sH3iFA8+8Xf`(c` 8)
OTAT will not commit to reviewing packages greater than 250-300 pages or answering questions that require review of this much material. The .gov means its official.Federal government websites often end in .gov or .mil. Instead, the meeting requestor may consider submitting the product manufacturing information in a Master File (MF) to OTAT so that IND sponsors using the product can crossreference the MF. The .gov means its official.Federal government websites often end in .gov or .mil. Number of questions. Will vector shedding studies be required? The previous guidance for industry entitled Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants, issued on November 18, 2015, has been withdrawn. See INTERACT Meeting Section for information regarding INTERACT meetings. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). However, because OTAT staff will be familiar with the meeting package content and questions, OTAT recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTATs preliminary responses to the sponsors questions. The pre-IND meeting will be scheduled to occur within 60 days of receipt of the meeting request. Examples of reasons for denial are included below: The sponsors meeting package should include a limited number of clearly worded and targeted questions that directly address concerns about the product development programs. After receiving OTATs preliminary response, the sponsor. The sponsor may submit their version of the meeting minutes to the file to summarize their understanding of issues discussed at the meeting. Meeting packages are typically 50 100 pages. Written Response Only (WRO) is considered to be equivalent to 60 minute meetings. Such new questions/alternative approaches should be submitted as part of the original IND. Does the FDA agree that the data from the completed in vitro and in vivo proofof-concept (POC) studies are acceptable to initiate the proposed clinical trial? After receiving OTATs preliminary response, the sponsor. endstream endobj 533 0 obj <>stream In some situations, a sponsor may want to develop new questions/alternative approaches in response to OTATs preliminary responses or discussion at the meeting. A cover letter should be included in the briefing package with the inclusion of the assigned PTS number. A pre-IND meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold. Before sharing sensitive information, make sure you're on a federal government site. HWn8}WQ^uYtS^'m3h_I8b("^unj|,MaIwz?H*)8xOA,JK7CI8m?I ~WTU8e8&QbjvQ.bMSUXBc+ye&@d-h,418i#x./d&G#.FF\aq [3v6811Jl3%%J9I3zvO",I[7C" The format for pre-IND meetings is typically either a teleconference or Written Response Only (WRO). All written comments should be identified with this document's docket number: FDA-2018-D-1922. The meeting also provides an opportunity to discuss the plans for studying the product in pediatric populations, the target product profile, the quality target product profile, the design and results of any natural history studies, and the best approach for presentation and formatting of data in the IND.
The subject line of the email should include the assigned PTS number and meeting briefing package. The meeting request does not include specific questions or the questions are not appropriate for a pre-IND meeting. Whether the sponsor had a prior pre-IND meeting with OTAT for the same or similar product or indication. Therefore, attempts to separate meetings into discipline-specific discussions can lead to inadvertent miscommunication and duplication of effort. The OTAT responses can be interpreted ambiguously and are unclear to the sponsor (e.g., Did you mean A or B?), Questions related to new information not included in the briefing package, Questions related to the adequacy of new proposals to address OTAT comments [e.g., new clinical trial designs, study endpoints, new patient population, new/modified assays, new preclinical study design, new materials (i.e., raw materials, source materials)]. As stated above, during the meeting the OTAT team will not be able to provide feedback on new information (e.g., new questions, alternative approaches or new proposals to address OTAT comments) that was not previously submitted in the original briefing package. However, OTAT may not review such submissions; therefore, the absence of an OTAT response to such submissions does not imply OTAT concurrence with the sponsors version of the minutes. Sponsors should pose clear, focused questions so that OTAT can provide advice targeted to the specific product development program. *** Calendar days from FDA receipt of the meeting request to date the meeting will be held, or the WRO will be issued. Cellular & Gene Therapy Products, Recalls, Market Withdrawals and Safety Alerts, Approved Cellular and Gene Therapy Products, Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry, Determining pre-IND meeting format (e.g., Written Response Only (WRO) vs. teleconference), Common reasons for denial of a pre-IND meeting request, SOPP 8301: Receipt and Processing of Master Files, Examples of pre-IND meeting package content (CMC, P/T, clinical), Examples of questions appropriate for a pre-IND meeting (CMC, P/T, clinical), Examples of questions that are not appropriate for a pre-IND meeting, Best Practices for Managing Pre-IND Meetings with OTAT, At least 30 days before the scheduled date of the meeting or WRO. endstream endobj startxref Is the delivery device compatibility plan sufficient? OTAT will not provide the sponsor with minutes for such informal teleconference. hbbd``b`:$W@HuYw0 B Not for implementation. hbbd``b`k`;$A\ Z r_O r Table: Timelines for Pre-IND (Type B) Meetings. OTAT recommends that time be reserved at the end of the meeting for the sponsor to summarize the major discussion points and action items. 134 0 obj <>stream 0 Is the study population, as described in the enrollment criteria, appropriate for the proposed first-in-human (FIH) study? To ensure that the appropriate FDA staff are assigned to the meeting, the meeting request should include draft questions. 1919 0 obj <>/Filter/FlateDecode/ID[<5C91AEC681E59649AA1ED405CB3BC087><3D2E9DFB47A6E641ADD5CAC9246F5847>]/Index[1901 47]/Info 1900 0 R/Length 88/Prev 317242/Root 1902 0 R/Size 1948/Type/XRef/W[1 2 1]>>stream Draft questions submitted in the meeting request can be refined with the submission of the meeting package. All written comments should be identified with this document's docket number: FDA-2022-D-0080. If the sponsor finds that OTATs preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTAT in writing as soon as possible so that OTAT may cancel the meeting. As a rule, the meeting discussion follows the prioritized order of importance set by the sponsor, with the understanding that all questions may not be addressed due to time constraints. kLa2\p.>:o'? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Description of the product, manufacturing process and testing conducted (inprocess / final product) to demonstrate product identity, quality, and safety, Description of product formulation and storage conditions, Detailed descriptions of any CMC issues on which feedback is being requested (e.g., sourcing of starting materials, potency assessment). Written Response Only (WRO) is considered to be equivalent to 60-minute meetings. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester (s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or written response only (WRO)). HUnFCmzx8 _z.IOMf@z^n$`Y0 B$" !c/'*STk>a" abP`~h. (*(%8H8c- fd9@6_IjH9(3=DR1%? The meeting request is substantially incomplete based on the omission of one or more of the elements identified in the. 0
The sponsor should provide a clinical trial protocol synopsis or draft protocol that includes, but is not limited to: The maximum number of questions that can be covered in a preIND meeting is 12. In some situations, OTAT may suggest an INTERACT meeting. Sponsors should consider this limitation and identify the most important questions for their specific development program. Are the Dose-Limiting Toxicity criteria acceptable? Does OTAT agree with the approach used to determine the proposed starting dose and dose-escalation plan for the product in the proposed Phase 1 trial? However, because OTAT staff will be familiar with the meeting package content and questions, OTAT recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTATs preliminary responses to the sponsors questions. 1901 0 obj <> endobj Does the FDA agree that the overall preclinical program is adequate, pending the study results, to support the proposed Phase 1 clinical trial? The meeting request should include a list of the specific objectives of the meeting and a list of questions [grouped by discipline, e.g., Chemistry, Manufacturing, and Controls (CMC), pharmacology / toxicology, clinical, statistical]. The clinical assay, xxx, will be used to determine patient eligibility for study enrollment.
109 0 obj <> endobj The sponsor should include their request for clarifications for all disciplines in a single follow-up request. )/q/lkeEWcKaz_7j6}coz+;\gkz"^F6/$oZxmtKT01 ySwxQn@Eq8h|VMxuK0lo>5wv\g5BTpmc/2*N7o4 1"I,j!N G : You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). endstream endobj 529 0 obj <>/Metadata 41 0 R/Outlines 68 0 R/PageLayout/OneColumn/Pages 524 0 R/StructTreeRoot 107 0 R/Type/Catalog>> endobj 530 0 obj <>/Font<>>>/Rotate 0/StructParents 0/Type/Page>> endobj 531 0 obj <>stream Whether the sponsor had a previous or current IND for the same or similar product or indication. OTAT will consider the follow-up request, and if determined to be limited to clarification, OTAT will issue a response in writing within 20 calendar days after receipt of the clarifying questions. Whether the questions are straightforward or complex. Simple requests for clarification of OTAT WRO may be sent to the Regulatory Project Manager (RPM) within 20 days after receipt of the WRO. If the sponsor finds that OTATs preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTAT in writing as soon as possible so that OTAT may cancel the meeting. The number of questions in a meeting package should not exceed what can be reasonably discussed within the duration of the allotted meeting time. in all areas. Description of devices that will be used for product administration or cell selection, A comprehensive discussion regarding the justification for all elements of the preclinical program, A comprehensive summary of all completed preclinical studies (in vitro and in vivo studies, animal species / models, study designs, resulting data and interpretation), Complete protocols for the proposed definitive preclinical safety / toxicology and distribution studies, with sponsors rationale for the respective study design (e.g., animal species/models, dose levels, dosing regimen and procedure, study endpoints, sacrifice intervals), intended patient population (e.g., age, severity of disease, phenotype), delivery procedure, including device (as applicable), Safety and preliminary efficacy endpoints (e.g., outcome measures). 5630 Fishers Lane, Rm 1061 Does the FDA agree with the stability testing of the drug substance and drug product? *** Calendar days from FDA receipt of the meeting request to date the meeting will be held, or the WRO will be issued. An official website of the United States government, : endstream endobj 1 0 obj <>/Font<>>>/Rotate 0/StructParents 1/Type/Page>> endobj 2 0 obj <>stream Sponsors should also refer to available FDA guidances applicable to their product. OTAT schedules Pre-IND meetings for 60 minutes. Rockville, MD 20852. For a 60-minute meeting, a maximum of 12 questions (inclusive of sub-questions) would be considered reasonable. OTAT evaluates each meeting request to determine whether to grant or deny the meeting, and to determine the appropriate format for the meeting. Food and Drug Administration The meeting package for a pre-IND should be submitted no later than 30 days before the scheduled date of the pre-IND meeting or WRO (see Table above). If sponsors disagree with the content of OTATs minutes, OTATs meeting minutes will not be altered except to correct a substantive mistake for the record (on extremely rare occasions). The site is secure. The .gov means its official.Federal government websites often end in .gov or .mil. Source: Tableinformation from the Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry The sponsor has completed proof-of-concept (POC) and possibly some preliminary preclinical safety/toxicology studies and desires to move to the definitive toxicology studies. For example, a question such as whether the overall proposed manufacturing approach or clinical program is adequate for enabling the IND is too broad. Does the FDA agree that the animal species / model evaluated in the POC and toxicology studies is acceptable? Whether the preclinical testing and manufacturing process for the product use the same/similar platform as other product(s) submitted to OTAT by the same sponsor. h_k0`I,JVX:(}$. Contains non-binding recommendations. The academy is established to help players from Ghana and across Africa gain recognition and advance their football careers. If the meeting requestor intends to manufacture and provide their product to other investigators to conduct IND studies, OTAT will not grant a Type B pre-IND meeting to discuss product manufacturing. hb```d @`Q|G= vvm6O?jr|` 3Q@ m=fbBx8n875$sH3iFA8+8Xf`(c` 8)