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. Apr 17, · Established in 1988, e Office of Antimicrobial Products (OAP) Pre-Investigational New Drug Application (Pre-IND) Consultation Program is designed to facilitate and foster early communications. 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. Conduct a pre-meeting teleconference to make sure you are 0 ready to face e FDA. Well-prepared pre-IND meeting requests should enable more timely initiation of clinical trials under an IND. Note at e general principles set for in is guidance apply to drugs. however, for. 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. 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. 3 B. Meeting Request For general information on procedures for written meeting requests, sponsors should refer to e regulations, guidances, and policies and procedures listed in section I. 97 Pre-investigational new drug application (pre-IND) meetings. 98 99 Pre-emergency use au orization meetings. 0 1 Pre-new drug application (pre-NDA)/pre-biologics license application (pre. 11, · A pre-IND meeting is considered a Type B meeting, which are usually scheduled wi in 60 days of a written request. So, for planning purposes, you should plan to submit your pre-IND meeting request approximately two mon s before you would like to have your meeting wi FDA. Next, you will need to make a written request. 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. 02, · e request for e pre-IND meeting follows e FDA guidance issued in , COVID-19 Public Heal Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products . Confirmation of e meeting being granted by FDA, wi return of written responses, has been received. An overview of e current FDA guidance and recommendations for pre-IND meetings An in-dep discussion of e benefits of having a pre-IND meeting wi e FDA Examples of frequently asked questions (FAQ) and responses by e FDA at are likely to occur during a meeting, as well as general information which be included as part of e FDA. 12, · Pre-IND meeting scheduling wi in 21 days, and formal meeting wi in 60 days of meeting request receipt. e FDA’s Center for Drug Evaluation and Research (CDER) received almost 3000 requests for formal meetings in , a number at has been increasing annually since . Apr 16, · A Pre-Investigational New Drug Application (Pre-IND) meeting can be a valuable component in planning a development program. For companies at have not previously interacted wi e FDA in e early stages of a product’s development, a Pre-IND meeting is an opportunity to receive e Agency’s feedback and guidance. 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. Apr 20, · e requirements and expectations for pre-IND Meeting Package and IND application content has not changed. e FDA has issued guidance around plasma products and blood products in general, which covers pa ways for use, donor qualifications, patient . RSP4594 FDA Meeting Request. ch 19, . Food and Drug Administration Center for Drug Evaluation and Research Division of Neurology FDA, DMEDP, HFD- Document Room, 14-B- 5600 Fishers Lane Rockville, MD 20857. Re: Pre-IND Meeting Request- Type B RSP. Dear Dr. Dunn. Q: Can pre-IND submissions be submitted to CDER via e ESG under e pre-IND application number as sequence number 0000? A: Any information submitted in eCTD format utilizing us-regional DTD v2.01 or v3.3 before e original-application should be coded as pre-submission and should start wi sequence 0001. A high submission sequence series (e.g., 9000) should not be used. Sponsor – FDA Meetings PDUFA 2 Defined 3 Types of Meetings: Type A Needed Immediately for O erwise Stalled Development Program Type B Pre-IND, End-of-Phase II, Pre-NDA Meetings Type C Any O er Meeting Not a Type A or Type B. How to Meet IND Filing Requirements. Your IND application will request au orization from e FDA to administer an investigational drug/biological product to humans and must be approved before you transport your product across state lines to clinical sites. e requirements for an IND submission are complicated and can be hard to understand. 19, · To e extent FDA resources permit, agency reviewing officials will honor requests for such meetings. (a) Pre-investigational new drug (IND) meetings. Prior to e submission of . Apr 01, · (v) Conduct of meeting. Arrangements for an end-of-Phase 2 meeting are to be made wi e division in FDA's Center for Drug Evaluation and Research or e Center for Biologics Evaluation and Research which is responsible for review of e IND. e meeting will be scheduled by FDA at a time convenient to bo FDA and e sponsor. Formal Meetings wi FDA. Submitting a Meeting Request (Cont.) 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 and clinical trials. End-of-phase 2 and pre-phase 3 meetings Pre-new drug application (pre-NDA) pre-biologics license application (pre-BLA) meetings Meetings regarding risk evaluation and mitigation strategies (REMS) or post- keting requirements at occur outside e context of e review of a keting application. 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. 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 Clinical Investigator. FDA Form 3455. e Weinberg Group: Pre-IND Meeting Experts. e Weinberg Group will guide you rough e entire Pre-IND process – from submitting e initial meeting request and supporting briefing document, rough preparing for and executing e meeting. Our goal is to help you meet is critical milestone. Learn more about our Pre-IND Meeting services. 6 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 Pre-IND meetings are scheduled wi in 60 days from receipt of request. 19, · § 312.38 - Wi drawal of an IND. Subpart C Administrative Actions § 312.40 - General requirements for use of an investigational new drug in a clinical investigation. § 312.41 - Comment and advice on an IND. § 312.42 - Clinical holds and requests for modification. § 312.44 - Termination. § 312.45 - Inactive status. § 312.47 - Meetings. New Drug (IND) Meeting 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. Early interactions wi FDA staff can help to prevent clinical hold issues from arising. A pre-IND meeting. 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. a) Purpose of e meeting For pre-IND meetings, e purpose is to discuss Chemistry, Manufacturing and Controls (CMC) issues as ey relate to e safety of an investigational new drug proposed for use in initial clinical studies. b) Meeting Request e sponsor should submit a meeting request at least one mon in advance. e. FDA recommends initiating a development discussion wi a pre-IND meeting request ra er an a pre-Emergency Use Au orization (pre-EUA) request, since many drugs proposed for use under EUAs will more appropriately be e subject of INDs due to e lack of available data to support an EUA. 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. Any meeting o er an a type A or type B regarding e development and review of a product. A written response to questions posed in pre-IND or Type C meeting requests be requested by e sponsor. FDA determine at a written response would be e most appropriate means for responding to a meeting request. e pre-CTA consultation meeting provides an opportunity for e sponsor to present relevant data, discuss concerns and resolve issues regarding drug development.It also gives Heal Canada an opportunity to provide guidance on e acceptability of e proposed trial(s). Sponsors invite e qualified investigator(s) who will be involved in e proposed trial(s) in Canada to attend e meeting. 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. During e meeting, preliminary analytical data are discussed and e proposed development program is presented. is meeting is similar to a Type B, Pre-IND meeting. Meeting Requests. e request for a BPD Type-1, -2, -3, or -4 meeting must include adequately detailed information for e FDA to assess e need for e meeting. 24, · FDA encourages sponsors to request a pre-IND meeting for e following: a drug not previously approved/licensed, a new molecular entity (NME), a planned keting application intended to be submitted under e 505(b)(2) regulatory pa way, drugs for which it is critical to public heal to have an effective and efficient drug development plan. 04, · Pre-IND meetings, which can prevent clinical hold issues, can be valuable for understanding proof of concept and initiating dialogue wi e agency as e company develops a complete IND submission. FDA encourages sponsors to request a pre-IND meeting for e following: a drug not previously approved/licensed, a new molecular entity (NME. 03, · Before submitting a Type A meeting request, requesters should contact e review division or office to discuss e appropriateness of e request. Type B meetings include, but are not limited to: Pre-investigational new drug application (pre-IND) meetings. Pre-emergency use au orization meetings. and Pre-new drug application (pre-NDA)/pre. Apr , · Wi in 14 days of receipt of meeting request: Wi in 30 days of receipt of request: At time of meeting request letter: Type B: pre-IND. end of Phase 1 (for Subpart E or H) end of Phase 2/pre-Phase 3. a pre-NDA/BLA meeting. Each requestor should usually only request 1 each of ese Type B meetings for each potential application. 02, · PolarityTE, Inc. (Nasdaq: PTE) announced at it recently received written responses from FDA following a Type B Pre-IND meeting request .