If you are submitting a paper submission, Please submit 3 copies of e request to e address above and clearly indicate in your cover letter at e enclosed is a Pre-IND submission. A sponsor consult wi e Agency before formal submission of an IND application and send a pre-IND meeting request (PDF - 145KB) to an appropriate Review Division responsible for overseeing. Re: Pre-IND Meeting Request- Type B RSP Dear Dr. Dunn, Alexandria Pharmaceuticals is hereby requesting a pre-IND meeting, to be held at e Division’s earliest convenience, to discuss our plans for developing RSP4594, which has Clonazepam as e active pharmaceutical ingredient and is an anticonvulsant indicated for Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic 4.8/5(23). 12, · In e Commitment letter for PDUFA VI (covering fiscal years – 2022), a Sponsor request for WRO has been expanded to include any type of meeting (PDUFA V includes is option for Pre-IND and Type C meeting requests). e provision of WRO by e FDA despite a Sponsor’s request for a live meeting remains a listed option for Pre-IND and Type C meetings. 86 Meetings requested wi in 30 days of FDA issuance of a refuse-to-file letter. To file an 97 Pre-investigational new drug application 113 meeting request meets e criteria for a Type. e pre-IND meeting can be very valuable in planning a drug development program, especially if sponsors' questions are not fully answered by guidances and o er information provided by FDA. IND ision Tool. IND Exemption Letter. Pre-IND Briefing Packet. Pre-IND Meeting Request. IND Submissions. IND Checklist for IND Submission. FDA Form 1571 - IND Application. FDA Form 1572 - IND Investigator Statement. FDA Form 1572 (Box 8) - Protocol Sum y Template. FDA Form 3454 - Certification: Financial Interests and Arrangements of. If a Pre-IND meeting request or IND is submitted to study various solid tumors and hematologic malignancy indications, whereby specific indications for drug development have not yet been identified. An INTERACT meeting enables sponsors to obtain preliminary informal consultation for in ative investigational products at an early stage of development on issues at are not yet at e pre-IND. Information to include in a meeting request (Cont.): A brief statement of e purpose and objectives of e meeting. Brief background of e issues. A brief sum y of completed or planned studies. Details for requesting a formal meeting wi CDER is outlined in FDA's Guidance for Industry: Formal Meetings Between e FDA and Sponsors or Applicants. Information in a meeting request should include: Product name. Application number (if applicable) Chemical name and structure. Proposed indication(s) or context of product development. After you request e meeting by letter or e-mail, e FDA will respond wi a date wi in 2 weeks. You must provide a 'Pre-IND package' at least 4 weeks prior to e scheduled meeting date. A Pre-IND package is background information. 03, · If a meeting request is denied, e FDA will notify e requester in writing. e FDA’s letter will include an explanation of e reason for e denial. Denials will be based on a substantive reason, not merely on e absence of a minor element of e meeting request or meeting package . Information to include in a meeting request (Cont.): A list of FDA staff or disciplines asked to participate in e requested meeting. Requests for FDA staff impact e meeting time frame. When requesting non-essential FDA staff, specify whe er a later meeting date is acceptable. Engaging wi e FDA During New Drug Development. Formal Meetings wi FDA. Questions to Ask FDA during Formal Meetings. CDER review staff encourages e sponsor to submit clearly worded questions. Click on each meeting type to learn more. Pre-IND Meeting Questions. EOP1 Meeting . Apr 16, · e first step is to submit a Pre-IND meeting request letter wi e questions for e FDA to answer. Asking e appropriate questions is critical because e FDA uses information in e request letter to determine (a) if a face-to-face or teleconference meeting or written responses should be granted (or denied) and (b) which reviewers will be at e meeting to facilitate a productive discussion. Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format wi e initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes e IND number, and Module 1 includes at least two places at are appropriate for including Pre-IND documents (ei er Module . Pre-Investigational New Drug Application (pre-IND, PIND) meetings are defined in 21 CFR 312.82 Early Consultation. According to is regulation, Prior to e submission of e initial IND, e sponsor request a meeting wi FDA-reviewing officials. Pre-IND Meetings. (21 CFR 312.82) Request must be submitted in writing (fax is fine) and should include: Description of product. Description of clinical indication and approach. Identification of purpose, objectives, and draft of specific questions. Suggested dates and times for meeting. Request for Pre-IND Meeting Template. Download Request_For_Pre-IND_Meeting Template . Request for Pre-IND Briefing Meeting Template. Site footer content. Contact Us. Institute for Clinical and Translational Research 4240 Heal Sciences Learning Center . 31, · e process for requesting a pre-IND meeting starts by submitting a meeting request letter to e FDA which includes a draft of a brief product description, objectives and expected outcomes, proposed agenda, preliminary questions, sponsor attendees and proposed dates for e meeting. Handbook for Investigational New Drug (IND) and New Drug Application (NDA) following information and e templates for a meeting request letter and pre-IND briefing packet:. IND ision Tool: Pre-IND Consultation Contact List Request for Pre -IND Meeting Pre-IND Briefing Packet Types of Meetings wi e FDA 2. IND Required: Review e. Engaging wi e FDA During New Drug Development. contact eir project manager or call e review division’s Chief Project Management Staff prior to submitting a meeting request. Click to access a link to Division phone numbers. Click for more information on submitting a meeting request. D. IND Exemption Letter Pre-IND Consultation Contact List. Request for Pre-IND Meeting. Pre-IND Briefing Packet. Types of Meetings wi e FDA. Exemptions - A drug at is lawfully keted in e United States is exempt from e requirements for an IND if all of e following apply: e investigation is not intended to be reported to e FDA. 08, · A Pre-IND is a Type B meeting, also known as a milestone meeting. e FDA typically only grants one meeting for each milestone such as Pre-IND, End-of-Phase, and Pre-NDA meetings. is makes e conduct and preparation for ese meetings critical. e Sponsor determines e questions at it would like e FDA to answer. Center for Drug Evaluation and Research. Engaging wi e FDA During New Drug Development. Formal Meetings wi FDA. Q &. Question: What do I do if e list of attendees changes? Answer: You should inform your Regulatory Project Manager if e list of attendees changes. Food and Drug Administration Center for Drug Evaluation and Research Division of [ erapeutic Area] Central Document Room 5901-B Ammendale Rd. Beltsville, MD 20705-1266 Request for Pre-IND Meeting Dear Dr. [Division Director]: In response to our conversation on 18.01.2010, I am formally requesting a Type B meeting to discuss e proposed. 13, · Type C meetings are typically scheduled to occur wi in 75 days of FDA receipt of e written meeting request, as opposed to e 60 daysfor e FDA to grant a Type B meeting. Fur ermore, it is often difficult to fully debate e contentious points from e initial meeting wi in e time constraints of e Type C meeting, which could result. ReGARDD.org Resources e ReGARDD website is a collaboration between e regulatory affairs specialists from e Nor Carolina CTSA Institutions and is comprised of helpful tools, templates, ision trees, and educational resources to support academic investigators’ regulatory needs. Formal meetings wi FDA are very useful and impact drug development. 20 - Mean Development Time: Wi pre-IND meeting – 7.1 years. Wi out pre-IND meeting – 12.8 years. 5.7 years difference: Wi EOP2 meeting – 9.6 years. Wi out EOP2 meeting – 11.3 years. 1.7 years difference: D. USER INSTRUCTIONS. Pre-IND Request (see handout) Cover Letter (formal, see example) Product Name Chemical Name Chemical Structure Proposed Indication Type of meeting requested (Type B) Purpose of e meeting Expected Meeting outcomes Preliminary Agenda List of proposed questions Attendees Requested FDA staff Approximate date when e briefing package will be sent. e questions are sent to e FDA wi e Pre-IND Meeting request. Prepare e briefing package, making sure it includes an overview of your product, describes e purpose of e meeting, and at it includes appropriate clinical/manufacturing information. How to Get e Most out of Your Meeting – e Request Submit Request in Writing Clearly Identify Your Submission as a Meeting Request Include Relevant Background in e Request Objective / Expected Outcome Draft Questions (Wi Paragraph of Explanation*) Proposed Industry Attendees. Requested FDA Attendees Guidance for Industry, Formal Meetings wi Sponsors and Applicants. Sponsors can request FDA’s feedback in writing or in a formal meeting or teleconference wi e Agency. Pre-Submissions are not required, but if applicants seeking additional feedback from e FDA can submit a Pre-Submission prior to e filing of e following medical device applications: IDE. 5 (k) PMA. De o Request. HDE. CLIA Amendments. 23, · •Submit formal Pre‐IND Meeting Request in required format •FDA responds wi in 21 days of receipt: meeting granted or denied •If granted, meeting scheduled to occur wi in 60 days of request receipt •Pre‐IND Meeting Packagemust be received by FDA no later an 30 days before scheduled Pre‐IND meeting •FDA will send preliminary. Contact e Research Help Desk if you need assistance wi drafting communications to e FDA or for templates for any of e following items: Investigational New Drug (IND) Applications. Request for IND Exemption. Pre-IND meeting request and briefing package. IND Application. IND Annual Report. IND . 25, · Templates for a meeting request letter and pre-IND briefing packet are provided below. In addition, please consult wi e IRB to determine whe er a formal letter from FDA is required to document e waiver. IND Exemption Letter Pre-IND Consultation Contact List. Request for Pre-IND Meeting. Pre-IND Briefing Packet. IND Exemptions. 02, · e FDA has granted pre-IND meeting request to In ation Pharmaceuticals (OTCQB:IPIX +5.5) for its Brilacidin against COVID-19, submitted earlier is week.. In e application, e Company has. 06, · Oragenics (NYSEMKT:OGEN) jumps 19 pre ket after receiving feedback to Type B Pre-IND Meeting Request from e FDA at e Agency is in broad agreement wi e Company’s clinical development. 24, · Templates for a meeting request letter and pre-IND briefing packet are provided below. In addition, please consult wi e IRB to determine whe er a formal letter from FDA is required to document e waiver. IND Exemption Letter Pre-IND Consultation Contact List. Request for Pre-IND Meeting. Pre-IND Briefing Packet. 22, · In e past, small- to mid-sized sponsors would typically submit a Type B pre-IND meeting request (and its associated meeting package, also known as a briefing book) in paper format under a pre-assigned PIND number. Form FDA 1571 1.2 Cover Letters 1.6 Meetings 1.6.1 Meeting Request 1.6.2 Meeting Background Materials 21 CFR 312.23(e). 22, · In e past, small- to mid-sized sponsors would typically submit a Type B pre-IND meeting request (and its associated meeting package, also known as a briefing book) in paper format under a pre-assigned PIND number. e initial IND application would en be submitted in eCTD format, as eCTD sequence number 0000. 02, · PolarityTE, Inc. (Nasdaq: PTE) announced at it recently received written responses from FDA following a Type B Pre-IND meeting request . e following is an example of e types of material at will be required for FDA to make e best use of your Pre-Sub request: Cover letter explaining your reason for feedback. Preferred form of feedback (if you are requesting a face-to-face meeting or teleconference, please list 3 available dates/times for e proposed meeting) Table of Contents. One of e mechanisms for applicants to request feedback from e FDA is e pre-submission (pre-sub) process. In is process, a person or organization anticipating e need to make a future submission to e FDA (e.g., Investigational Device Exemption, 5 k Pre ket Notification, Pre ket Approval) can make a written request to obtain.