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. is guidance covers ree kinds of meetings at be held between sponsors and e Agency: (1) pre-investigational new drug application (pre-IND), (2) end-of-phase 2 (EOP2), and (3) pre-. 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. During is teleconference we will review possible . e FDA has a Pre-Investigational New Drug Application (Pre-IND) Consultation Program available to potential IND holders to facilitate early communications regarding an IND. e program allows e sponsor-investigator e opportunity to discuss e proposed project and receive guidance directly from e FDA prior to submitting an IND. Pre-IND Meeting Checklist. Find out to whom you should request e pre-IND meeting, e.g. e FDA reviewer in e Division of Neurology or Gastroenterology (see FDA website below for contact information). 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. 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. Contact Us. Institute for Clinical and Translational Research 4240 Heal Sciences Learning Center 750 Highland Avenue Madison, WI 53705. Email: [email protected] Phone: (608) 263- 18. In e current regulatory environment, pre-IND meetings are often granted as a WRO in which e Agency will provide written responses to e questions in e meeting package and reviewers’ comments about e information contained wi in e meeting package in lieu of a meeting. FDA Guidance Documents consultation for in ative investigational products at an early stage of development on issues at are not yet at e pre-IND meeting phase. e INTERACT program. MEETING PACKAGE 25 guidance, formal meeting includes any meeting at is requested by a sponsor or applicant 97 Pre-investigational new drug application (pre-IND) meetings. 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. FAQs about e Pre-IND Meeting. FDA Form 1571. FDA Form 1572. FDA Form 3454. FDA Form 3455. FDA Form 3674. Investigational New Drug Applications. UCSF Guidance for IND. Need assistance or have regulatory questions? Contents of a Pre-IND Meeting Package (cont’d) • Preclinical development program – A comprehensive sum y of all completed preclinical studies (in vitro and in vivo studies, animal models, study designs, resulting data and interpretation, etc.) – Complete protocols for your definitive preclinical. In general, Pre-IND meetings are granted as Written Responses only in lieu of a meeting. However, a teleconference or face-to-face meeting will be granted on a case-by-case basis. If a meeting. to a successful IND and development program. As progress is made tods an IND, e product sponsor or investigator often requests a formal pre-IND meeting wi e Food and Drug Administration (FDA). is formal meeting is beneficial when properly timed to . 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. 31, · e FDA allows for one pre-IND meeting prior to IND submission to discuss any questions or concerns concerning clinical trial approach. Any topics be discussed during is meeting including questions concerning general product development, manufacturing information, nonclinical testing, protocol design or o er regulatory questions. 29, · FDA Releases Draft Guidance on Treatments for Rare Diseases. e U.S. Food and Drug Administration (FDA) released new draft guidance to assist sponsors of treatments for rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. e guidance was announced at e NORD (National Organization for Rare Diseases) . 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. Gerald Yakatan, Ph.D., Founder, Chairman & CEO of IRISYS, has ades of pharmaceutical development, clinical trial strategy and design, and regulatory affairs experience.He interacts wi high-level FDA personnel and has planned and engaged in numerous FDA pre-IND meetings . 12, · Tips for Optimizing Feedback From Written Responses Only. As we frequently blog, ere is no substitute for orough preparation for a Pre-IND Meeting. is includes asking e right questions, providing e right background information in a logical, concise manner, and most importantly for a product intended for e 505(b)(2) pa way, mapping out e development program for FDA feedback. Type B: Milestone Meeting (pre-IND, End of Phase 1 or 2, pre-NDA) Submitted in Background Package Sent 24-48 Hours Before Meeting Guidance Meetings Can be Held at Request of Sponsor or FDA to Discuss Any Issues. 03, · A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/ videoconference meetings or written responses only, what sponsors should include in at request, how FDA can respond, how long e agency can take to respond, and how e sponsor and FDA can go about conducting efficient, consistent, timely and . 01, · is draft guidance is intended to assist sponsors of drug and biological products for e treatment of rare diseases in early development and in e planning of and participation in formal pre-investigational new drug application (pre-IND) meetings wi FDA. e purpose of is draft guidance is to assist sponsors of drug and biological products for e treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Drug development for rare diseases has many challenges related to e nature of ese diseases. 13, · Instead, some Sponsors have tried to go around e Pre-IND meeting by submitting exploratory questions to e Agency, only to have e Agency lare e questions to be e Preliminary meeting package, and eir response to be e Pre-IND Written Responses. erefore, e Sponsor has lost e ability to have a full, detailed Pre-IND meeting. A pre-IND meeting is a formal meeting wi e FDA to discuss e contents of your future IND. e pre-IND meeting is an opportunity to build a relationship wi e FDA and gain valuable feedback on any questions you have regarding e development of your drug or biologic. Information on e stability program should be provided here or reference e drug manufacturers Drug Master File]. Drug Product [Here you should describe how e product will be prepared, e form at will be given to subjects, and any information on e instructions at subjects will be given for administration.] Pre-IND Briefing. 11, · Each meeting type is subject to different timelines and procedures. 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. 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. e FDA Draft Guidance Investigational New Drug Applications (INDs) – Determining Whe er Human Research Studies Can Be Conducted wi out an IND provides more detail on a range of issues, including e process for consulting wi FDA. If you ink a pre-IND meeting is ranted please contact e HUB for assistance. Templates for a meeting. 19, · While e program can be utilized wi standard milestone meetings (e.g., Pre-IND, End-of-Phase, and Pre-NDA/BLA), one advantage of participating in is program is at it can grant a sponsor e opportunity to speak wi e FDA outside of a standard milestone meeting. Applying to e program is straightford and e FDA has outlined. In addition to pre-IND meetings, e FDA offers o er opportunities to formally engage for guidance on development programs. 1 Type A meetings are held to help move along a stalled development program. Reasons for stalled programs might include dispute resolutions, issues wi e program at have put e clinical program on hold, or special. 19, · (a) Pre-investigational new drug (IND) meetings. Prior to e submission of e initial IND, e sponsor request a meeting wi FDA-reviewing officials. e pri y purpose of is meeting is to review and reach agreement on e design of . Pre-investigational new drug application (pre-IND) meetings End-of-phase 2 and pre-phase 3 meetings. Pre-new drug application (pre-NDA) pre-biologics license application (pre-BLA) meetings Meetings held to discuss e overall development program for products granted Break rough erapy designation status. Meeting Attendees. Proposed Meeting Dates (unless written feedback is requested). *Reference e latest FDA Guidance on Q-subs and Pre-submission requirements here. Note - e FDA frequently updates eir websites and guidances. As of ober , e guidance is only a draft guidance and change in e future. 04, · 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. STEP BY STEP GUIDANCE FOR SPONSORS-INVESTIGATORS TO A SUCCESSFUL IND SUBMISSION If you are uncertain and ink a pre-IND meeting is required, use e e information in e product label or package insert might suffice for e manufacturing information. PRE-IND BRIEFING PACKAGE If e FDA meeting is granted, sponsors must provide a pre-IND meeting briefing package to e Division of Transplant and Oph almology Products at least 4 weeks prior to e meeting.1Meeting packages are much more detailed an meeting request letters and should provide sum y information relevant to e product, organized according to e proposed agenda. Type A meeting package should be submitted wi e meeting request. It is best for a sponsor to contact e review division ey plan to submit to and follow eir advise. How to Submit a Meeting Package to CDER. D. USER INSTRUCTIONS: Click NEXT to continue. Page 32 of 38. FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH MEMORANDUM OF MEETING MINUTES Meeting Type: Type B Meeting Category: Pre-BLA Meeting Date and Time: ember 13, at 8:30 am ET Meeting Format: Teleconference Application Number: IND 113306 Product Name: risankizumab injection, 90 mg/mL Proposed Indication: for e treatment . Consequently, Pre-IND meetings are an opportune time for CT/GT sponsors to align wi FDA on CMC strategies at will allow for product development while maintaining regulatory compliance. e following examples highlight CMC-specific topics at sponsors should address during Pre-IND discussions for CT/GT products.. Selection Of Raw Materials. 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. 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.