IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 61 Rockville, MD 20852. Briefing package Wi meeting request 1 mon 1 mon IND - Investigational New Drug NDA - New Drug Application FDA Internal Pre-Meetings. 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 challenges by e FDA . meetings, and reviewing and responding to pre-IND meeting comments from e FDA to provide general recommendations for organizations looking to make e most out of eir pre-IND meeting wi FDA. 1.2. Purpose Pre-Investigational New Drug Application (pre-IND, PIND) meetings are defined in 21 CFR 312.82 Early Consultation. 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. 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. A Pre-IND package . Formal Meetings Between e FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry ember . Download e Draft Guidance Document Read e Federal Register Notice. 97 Pre-investigational new drug application (pre-IND) meetings. 98 99 Pre-emergency use au orization meetings. 0 1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. 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 - Investigator Financial Interest Disclosure. 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. 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 Questions. EOP2 Meeting Questions. Pre-NDA/BLA Meeting Questions. Pre-investigational new drug application (pre-IND) meetings. Certain end-of-phase 1 meetings for Subpart E or Subpart H or similar products. 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. Meetings wi e FDA Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA. Type B: Milestone Meeting (pre-IND, End of Phase 1 or 2, pre-NDA) Background Package Submission. 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. Meet wi you to prepare for an FDA pre-IND Meeting Prepare a Briefing Book at includes a rationale for recommended clinical studies and o er FDA pre-IND Meeting guidance Prepare your FDA Pre-IND Meeting presentation Accompany you to e FDA Pre-IND Meeting. 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. 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. 31, · e FDA will respond to your briefing package about 24 hours before e meeting, providing you time to review eir responses prior to your discussion wi em. If eir written response is sufficient, e meeting can be cancelled. e meeting should be . 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 . Contents of a Pre-IND Meeting Package •A background synopsis and sum y describing e manufacturing development of e subject investigational clinical product – A description of e product manufacturing process and testing conducted (in-process/final product) to demonstrate product identity, quality, and safety. Now, you need to make sure it will receive FDA approval. e key to achieving is is a perfectly executed Pre-NDA Meeting. A Pre-NDA Meeting enables sponsors and e FDA to ensure your NDA submission is well-organized and set up for success. is meeting should generally occur no less an 60 days prior to e submission date. 03, · For example, a meeting can be denied because it is premature for e stage of product development or because e meeting package does not provide an adequate basis for e meeting discussion. us, e FDA will generally deny requests for Type A meetings and Type C meetings to discuss e use of a bio ker as a new surrogate endpoint at has. Submit desk (paper) copies of meeting packages to e Regulatory Project Manager Contact e Division regarding submission format. 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. 30, 2008 · Before filing an IND, it is desirable (we counsel imperative) to have a pre-IND meeting wi e FDA. e goal is to get FDA’s concurrence wi e proposed development plan and regulatory submission pa way. e steps for is meeting (known as a Type B meeting) include: Prepare a pre-IND submission package. Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before e submission of clinical data or a new drug filing. Type C meetings, which is a catch-all category for any meeting . Formal Meetings wi FDA. Submitting a Meeting Package (Cont.) Meeting packages (Cont.): A brief statement sum izing e purpose of e meeting. A proposed agenda. A list of e final questions for discussion grouped by discipline and wi a brief sum y for each question to explain e need or context for e question. Feb 01, · Only 2 of 19 INDs () were submitted by sponsors wi substantial regulatory experience. Seven of 19 INDs (37) had pre-IND meetings wi PQ/CMC related questions for FDA feedback (one pre-IND meeting package did not contain PQ/CMC questions), but e meeting did not appear to have an impact on IND outcome. 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. 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. 27, · Generex Biotechnology Announces at FDA has Accepted e Pre-IND Briefing Package for e Company’s Ii-Key-SARS-CoV-2 Vaccine and Will Provide a Au or: Generex Biotechnology Corporation. Pre-IND Meetings are recommended by e FDA to help act as your expert communicators to FDA. • Prepare e meeting briefing book – preparations should begin on e briefing book at e same time at you begin e meeting request. Usually, your package is due to FDA 30 days before. 08, · VB-601 is e Company’s lead anti-MOSPD2 antibody for immune-inflammatory indications, for which a briefing package for e pre-IND meeting was submitted in e. Based on e FDA's feedback, VBL plans to advance its IND-enabling activities for VB-601 as planned. pre-ind briefing packet [compound x] table of contents. introduction 1.1. clinical background 1.2. regulatory background 1.3. pharmacological class 1.4. mode of action 1.5. proposed clinical indication 2. pharmacology 2.1. in vitro pharmacology 2.2. in vivo pharmacology 2.3. pharmacokinetics 3. clinical plan 3.1. sum y 3.2. title of study 3.3. 20, · Generex Biotechnology Files Pre-IND Briefing Package wi FDA for Ii-Key-SARS-CoV-2 Peptide Vaccine Against e COVID-19 Pandemic Email Print Friendly Share y 20, 09:00 ET. Au or: Generex Biotechnology Corp. 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. PRE-IND MEETING BRIEFING Examples: e requested meeting is a Pre-IND meeting to discuss e is section be covered by providing Package Insert of e FDA Pre Ind Meetings - Download as PDF EOP2 meeting briefing package • Sum ies of Phase 1 and Phase 2 investigations • Sum y information on plans for. , · In accordance wi e FDA’s industry guidance for COVID-19 biological products, Equillium has submitted a Pre-IND meeting request and supporting briefing package to FDA Au or: Equillium. 20, · Generex Biotechnology Files Pre-IND Briefing Package wi FDA for Ii-Key-SARS-CoV-2 Peptide Vaccine Against e COVID-19 Pandemic Read full article y 20, 6:00 AM. 6 mins read. 04, · e company will consider e feedback provided by e FDA in e development of e Pre-IND. ere is no set timeline for FDA to respond to a consultation package. however, based on pre . Apr 30, · Pre-IND Meeting • Hold e meeting early in e development process • Submit a complete briefing package on e proposed drug product • Submit specific questions and/or concerns regarding e nonclinical developpgment of e drug • Include pharmacologists and toxicologists who are involved in e nonclinical development of e drug 25. keting Applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA) Clinical & Non-Clinical Sum ies (Module 2) Integrated Sum ies of Efficacy and Safety (Module 5) Responses to Agency reviewers. Regulatory Briefing documents for Agency meetings, including: Pre-IND, End of Phase 1, End of Phase 2/3, Pre-NDA and Advisory. Citius Submits Mino-Wrap Briefing Package to FDA for Pre-IND Consult. e company has submitted a briefing package to e FDA Division of Anti-Infective Products. Meeting ose results. 19, · Refer to e FDA website for fur er information regarding e content and format of e MIDD package. Q4: How do I contact e FDA outside of an Investigational New Drug (IND) milestone meeting? e pri y contact for application-specific, technical, and scientific questions is e regulatory project manager (RPM) assigned to e IND.