Us fda type b meeting. FDA Modernization Act of 1997 Relationship.
Us fda type b meeting Jan 18, 2018 · As compared with Type B meetings, the FDA will aim to respond quicker to a Type B (EOP) meeting request; however, there will be a longer timeframe for scheduling the meeting and meeting packages will need to be sent in sooner due to the time required for FDA to review the greater volume of information contained in these meeting packages. Type A Meetings help an otherwise stalled product development program proceed or address a significant safety issue. Published on: Jul 21, 2022 The Food and Drug Administration (FDA) offers sponsors many opportunities for interaction and guidance during the course of drug development through routine formal meeting types including Type A, B, B (End of Phase (EOP)) and C meetings as outlined in Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry. The company faced significant challenges, including defining a robust Phase 1 strategy, summarizing extensive non-clinical data from over 40 studies, and addressing complex Apr 23, 2024 · This should be carefully considered against the type of IMP, phase of development and scope of questions for which the Sponsor is seeking advice. Sep 29, 2025 · FDA classifies sponsor-requested meetings into three categories: Type A Meetings: Urgent meetings to resolve stalled programs or critical clinical holds. 0 Purpose of the Pre-IND Meeting A pre-IND meeting is a Type B meeting held between a sponsor and the FDA. Pre-IND Meetings are Type B meetings and follow the timelines FDA had established for Type B meetings. 0 Procedure 4. Evolution of Meetings Offered by FDA The FDA has traditionally offered Type A, Type B and Type C meetings to Sponsors of an IMP seeking general guidance on a development program (Table 1). Mar 11, 2025 · Overall, meeting with the FDA has proven to decrease drug development time. Earliest is the Pre-IND meeting, the second is the End of Phase 2 (EOP2) meeting, and the third milestone is the Pre- NDA meeting. FDA has the option with these meetings to convert F2F requests to WRO. This update clarifies that a face-to-face meeting “includes in-person meetings and Nov 5, 2024 · Navigating FDA Type B Meetings: Case Study Overview APCER Life Sciences played a pivotal role in guiding a US-based biopharmaceutical company through a complex FDA Type B meeting for their oncology drug development program. BPD Type 2b Meeting is a meeting to discuss a specific issue (e. Meaningful, timely and formal FDA advice helps to de-risk and accelerate a product’s development . When it is determined that the meeting can be granted, but the questions and issues in the meeting request are more appropriately addressed through that different meeting type, FDA will notify the Apr 4, 2024 · Expert guidance to navigate successful FDA Type B meetings with CBER. Mar 9, 2025 · Maximize your FDA Type C meeting by engaging early, addressing regulatory challenges, and ensuring a smoother drug development process with expert strategies. FDA Modernization Act of 1997 Relationship. The agency offers three structured meeting types — Type A, Type B, and Type C — each serving a specific purpose at different points in the product development lifecycle. Mar 11, 2025 · FDA Type A meetings help resolve clinical holds and disputes in drug development. Industry Meeting Type describes the various types of formal industry meetings that occur. Typically, FDA meetings will only last one hour, PharmaLex US Partner Andrew Verderame has laid out a clear step-by-step guide to meeting with the FDA to help you get the most out of your meetings. 2 To submit a request for a Pre-IND (Type B) meeting with the FDA, prepare an electronic or written request to the appropriate FDA review division or office as follows. 4. , proposed study design or endpoints) or questions Mar 7, 2025 · Type B meetings occur at key points in development and are crucial for securing FDA guidance on study design, data adequacy, and regulatory expectations. Nov 8, 2019 · At Biopharma Excellence we are frequently involved in scientific advice procedures, going up to as much as six agency meetings a month covering FDA, EMA and national agencies in the EU. Source. Feb 26, 2024 · Discover the different types of formal FDA meetings for sponsors and applications including what to expect at each of these FDA meeting types. 1 Requests for Pre-IND meetings must follow FDA Guidances (See Section 5. To meet with the FDA, you will need to Sep 21, 2023 · The US Food and Drug Administration (FDA) has issued revised draft guidance to help sponsors understand the different types of meetings they can request for questions related to their applications and describes the timelines associated with these requests. It is 127 126 A Type C meeting is any meeting other than a Type A, Type B, or Type B (EOP) meeting 128 regarding the development and review of a product, including meetings to facilitate early 129 Mar 11, 2025 · Pre-NDA/Pre-BLA Meetings The pre-New Drug Application (NDA)/pre-Biologics License Application (BLA) meeting is a critical meeting between the sponsor and FDA to ensure the submission of a well-organized and readily reviewable NDA/BLA. Only biologics to treat serious or life- threatening illnesses (21 CFR 312 subpart E) and drugs under accelerated approval for serious/life threatening illnesses (21 CFR 314 subpart H) are eligible to request EOP1 meetings with the FDA. FDA meeting has a different agenda. g. There is no fee to the investigator associated with this meeting. Data Element Name. Sharing the results of early development work gives FDA reviewers insight into your product knowledge base and enables innovators (also called Nov 2, 2020 · 5. There are six types of formal meetings under PDUFA that occur between requesters and FDA staff: Type A, Type B, Type B (end of phase (EOP)), Type C, Type D, and Initial Targeted Mar 8, 2025 · Discover key strategies for navigating Type B FDA meetings, ensuring your meeting materials are well-prepared and improve your probability of success. Sep 3, 2025 · Overview of FDA Pre-Submission Meeting Types Interacting with the U. @ Feb 26, 2024 · Discover the different types of formal FDA meetings for sponsors and applications including what to expect at each of these FDA meeting types. Type B meeting is a pre-scheduled discussion with the FDA on specific topics related to drug development, ranging from pre-IND to post-marketing considerations. , meeting to discuss clinical holds, dispute Sep 2, 2022 · In Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1, Dr Kevin Bugin gave a PSUFA overview where additional type of meetings with FDA were discussed and FDA officer, Jeannie Roule presented "Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products". In this article we give some hands-on advice on how to successfully navigate through Type B and C meetings with FDA Aug 22, 2024 · Submission of End of Phase (Type B) Meeting Requests to OTP The sponsor should submit the meeting request as an amendment to the existing IND. Jan 27, 2025 · If a meeting request covers more than two topics or requires reviewers from three or more FDA disciplines, it will be denied and redirected to a Type B or Type C meeting. The PDUFA VII and BsUFA III commitment letters provide an update to the definition of face-to-face formal meetings with industry. Type B Meetings: Key development milestone meetings such as Pre-IND, End-of-Phase 2, and Pre-NDA/BLA meetings. Jun 24, 2022 · To support its mission of protecting and advancing public health, the US FDA has established formal mechanisms to engage with sponsors and applicants. Learn how to prepare, submit requests, conduct meetings, and follow up effectively. S. Learn about types, request process, timelines, and more. Meetings that are related to the development and review of drug or biological products regulated by the CDER or CBER. Context Before submitting an Investigational New Drug (IND) application, innovators can request a pre-IND (Type B) meeting with FDA. Meetings with the Agency are a critical component of the review and approval process for prescription drugs, biologics and medical devices. End-of-phase 1 (EOP1) meetings are formal PDUFA Type B meetings held between IND sponsors and CDER or CBER. This includes a discussion of the format and content of the anticipated application, and the presentation of data, the dataset structure, the acceptability of FDA Meeting Types: Timing, Purpose & Examples of Type A, B & C Meetings with CDER and CBER Meeting with the FDA to discuss your development plans can help reduce both costs and time to approval. FDA would convert a Type C meeting to a Type B because it was deemed a milestone meeting which may include any of the following: Generally, with the exception of products granted breakthrough Jan 31, 2023 · These meetings allow Sponsors to learn the FDA’s current thinking on a specific topic and to amend their development program based on FDA’s recommendations appropriately. Maximize your drug development success. The goal of this meeting is to review phase 1 Meetings between FDA and a sponsor at critical junctures in drug development can be especially helpful in minimizing wasteful expenditures of time and resources, thus speeding the drug development Typically, FDA meetings will only last one hour, and you will only have one chance to get it right, PharmaLex US expert Mark Lane has laid out a clear step-by-step guide to meeting with the FDA to help you get the most out of your meetings. Depending on the agency, timetables, meeting structure and conduct itself vary considerably. Biosimilar Product Development (BPD) Type 1 Meeting - A meeting which is necessary for an otherwise stalled drug development program to proceed (e. The FDA has issued a formal guidance on this entire process, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry. Regardless of the meeting type sought, it is essential that a Sponsor prepares well in advance for an FDA meeting in order to extract as much value as possible from the procedure. This is because each meeting occurs at a different point in the development continuum Aug 22, 2024 · Submission of End of Phase (Type B) Meeting Requests to OTP The sponsor should submit the meeting request as an amendment to the existing IND. Industry Meeting Type Description. During this meeting, the FDA provides feedback on the proposed strategies, helping to streamline the development process. Unlock the secrets of FDA meetings with our 5-part blog series. Knowing when In this case, a Type C meeting is more likely to be via teleconference or face-to-face. Food and Drug Administration (FDA) is essential for successful regulatory navigation, especially in drug, biologic, or device development. Topics can include dispute resolution, clinical holds, special protocol assessment meetings, and post-action after receiving an FDA regulatory action other than approval. This is because each meeting occurs at a different point in the development continuum Aug 22, 2024 · OTP schedules Pre-IND Meetings for 60 minutes. 0). May 18, 2021 · The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. The primary purpose of a pre-IND meeting is to discuss safety issues related to the investigational drug; issues related to pre-clinical studies, clinical trial design, and manufacturing; and to identify potential clinical hold issues. The pre-IND meeting is a critical milestone in the regulatory process; therefore, maximizing its value is important. Any meeting requested by a sponsor or applicant following the Guidance for Industry – Formal Meetings Between the FDA and Sponsor or Applicants of PDUFA Products. These meetings have a 60 day lead time and can be requested as in-person, videoconference, teleconference, or written response only (WRO). Discover the process, timeline, and key considerations for sponsors. • Type B Meetings are generally milestone meetings and often include pre-Investigational New Drug Oct 1, 2024 · The FDA offers several types of meetings, but the pre-IND meeting is categorized as a Type B meeting, which means that once the meeting request is received, the FDA will schedule it within 60 calendar days. Preparing For A Meeting With The FDA. pmtrmayiky7lkxrqpwo8ynal3lncyb8pwg06