Expertly Strategized and Executed Formal meetings with FDA can have a significant impact in reducing mean clinical development time.

Pre-IND, -NDA, and -BLA meetings play a pivotal role in enhancing the probability of a program’s success by enabling early resolution of concerns during the submission process. However, in the ever-changing FDA landscape, sponsors of various sizes often find it challenging to discern the criteria for success in these meetings and how best to prepare for them. https://youtu.be/vzFCPo9Ya5Y

Formal FDA Meetings Experts

At Snow Consulting, We offer expert outsourced consulting for all FDA meetings for drugs, biologics, and/or CMC-focused meeting. We offer custom regulatory affairs consulting services. However, we are there to meet your new surrogate endpoint, needs no matter your geographic location. We have over 35 Years experience in achieving success in all types of FDA meetings, offering sponsors valuable time-saving, efficient strategies before your next FDA engagement. We know FDA. So, give us a call to discuss your FDA meeting needs at 562-375-1411. We are located in the greater Los Angeles, CA area PST.

IND Filing Requirements

Each IND application should include the following:

• Form FDA 1571 (IND application cover letter)
• Form FDA 1572 (Investigator’s statement)
• Form FDA 3674 (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)
• Table of contents
• Introductory statement
• General investigational plan
• Investigator’s brochure
• Protocol(s): study protocol(s), investigator data, facilities data, Institutional Review Board (IRB), Chemistry, manufacturing, and control (CMC) data, including environmental assessment or claim for the exclusion (assuming the draft of CMC information exists)
• Preclinical: pharmacology and toxicology data
• Clinical: previous human experience
• Additional information to support the IND filing

Together with you, we will meticulously and carefully review the IND application. Our team will provide you with the final copy that is FDA ready for your Regops to submit. The IND application will go into effect 30 days after the FDA receives the application unless it was subject to a clinical hold from the FDA. Sometimes, the agency approves it earlier and notifies the Sponsor that clinical trials can begin.

Type A meeting serves as a crucial step to revive a stalled product development program. Here are some examples of situations where a Type A meeting might be necessary:

• Dispute Resolution Meetings: These meetings are to resolve differences between sponsors and FDA reviewing divisions with respect to requirements for IND’s as quickly and amicably as possible through the exchange of information and views. They include: Administrative and procedural issues, Scientific and medical disputes, end-of-phase 2 and pre-NDA meetings. Type A meetings provide an efficient and timely forum for discussing and resolvi8ng scientific and medical issues on which the sponsor disagrees with the agency.
• Clinical Hold Discussions: These meetings occur when a response to clinical hold issues has been submitted, yet both the FDA and the sponsor or applicant concur that the development is at an impasse and a new direction must be considered.
• Special Protocol Assessment Meetings: Requested by sponsors or applicants following the FDA’s evaluation of protocols under special protocol assessment procedures.

Before sponsors or applicants submit a request for a Type A meeting, it is advisable to contact the review division in either the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER) to ensure the request is appropriate. Type A meetings are intended to be scheduled within 30 days of the FDA receiving a written meeting request. Should a sponsor or applicant propose a meeting date beyond this 30-day window, the FDA will collaborate with them to identify the soonest mutually agreeable date.

Planning for a Type B Meeting: A Guide for Prospective Companies

As a prospective company preparing for pivotal stages in drug or biologic development, understanding the strategic importance of Type B meetings with the FDA is crucial. These meetings are designed to facilitate key discussions at various milestones in your development process, ensuring alignment with regulatory expectations and smoothing the path toward approval.

Types of Type B Meetings

Type B meetings encompass several critical stages in your product’s lifecycle, including:

• Pre-Investigational New Drug Application (Pre-IND) Meetings: These meetings lay the groundwork before submitting your IND application, allowing you to clarify initial development strategies and identify any potential regulatory hurdles early on.
• Pre-emergency use authorization meetings.
• Pre-New Drug Application (NDA)/Biologics License Application (BLA) Meetings: These sessions are essential for final preparations before submitting your NDA or BLA, helping to ensure your application is comprehensive and addresses all necessary regulatory requirements. Click Here for More on How To Have A Successful Pre-BLA Meeting with the FDA.

Scheduling and Planning for Type B Meetings

Type B meetings should be scheduled to occur within 60 days of the FDA receiving your written meeting request. If you need a meeting date beyond this 60-day timeframe, the FDA is willing to collaborate to find the earliest mutually agreeable date.

Optimizing Meeting Requests

To streamline the management of formal meetings, it’s beneficial to anticipate your future needs and, where practical, combine multiple product development issues into as few meetings as possible. Generally, the FDA grants only one of each Type B meeting for each potential application (such as IND, NDA, or BLA) or for closely related products developed concurrently (e.g., the same active ingredient in different dosage forms). However, there are exceptions:

• Separate Meetings for Unrelated Issues: When distinct issues necessitate separate discussions, the FDA may grant additional Type B meetings.
• Concurrent Development for Unrelated Claims: If you are developing a product for different indications simultaneously, it may be appropriate to conduct more than one of some Type B meetings.

Strategic Benefits of Type B Meetings

By engaging in Type B meetings, you can:

• Gain critical insights and feedback from the FDA to guide your development program.
• Address and resolve regulatory questions early, minimizing potential delays.
• Build a constructive dialogue with the FDA, fostering a collaborative approach to your product’s development.

Conclusion

As you navigate the complex landscape of drug and biologic development, leveraging Type B meetings effectively can significantly enhance your chances of success. Proper planning, clear communication, and strategic use of these meetings can help ensure that your development program proceeds smoothly, aligning with regulatory standards and ultimately bringing your product to market more efficiently.

Navigating the Path to Approval: A Guide to Type B (EOP) Meetings for Pharmaceutical Companies

As a pharmaceutical company striving to bring innovative drugs or biologics to market, engaging in strategic discussions with the FDA is a critical component of your regulatory journey. Among the various types of FDA meetings, Type B (End-of-Phase, or EOP) meetings hold particular significance, offering invaluable opportunities to gain feedback and alignment at pivotal stages of your development process.

Understanding Type B (EOP) Meetings

Type B (EOP) meetings are designed for specific milestones in your product’s development lifecycle. These include:

• End-of-Phase 1 Meetings: For products that are under consideration for marketing approval, these meetings provide a platform to discuss phase 1 clinical trial outcomes and outline the path forward. This stage is crucial for ensuring your development strategy aligns with regulatory expectations and addresses any early concerns.
• End-of-Phase 2 (Pre-Phase 3) Meetings: As you prepare to transition from phase 2 to phase 3 clinical trials, these meetings are vital. They allow you to review your phase 2 results, discuss your phase 3 trial design, and ensure your approach is robust and likely to meet FDA standards for safety and efficacy.

The Difference Between a Type B Meeting and a Type B (EOP) Meeting

While both Type B and Type B (EOP) meetings are essential touchpoints in the regulatory process, they serve different purposes:

• Type B Meetings: These meetings can occur at various stages of development and cover a wide range of topics. Examples include pre-IND meetings, certain end-of-phase 1 meetings (not necessarily those aimed at marketing approval), pre-NDA/BLA meetings, and more.
• Type B (EOP) Meetings: These are specifically focused on end-of-phase discussions, namely end-of-phase 1 and end-of-phase 2 (pre-phase 3) meetings. They are more narrowly defined, concentrating on the critical transition points that can significantly influence your product’s development trajectory.

Scheduling and Preparing for Type B (EOP) Meetings

To maximize the benefits of a Type B (EOP) meeting, it’s essential to schedule them at the appropriate stages and prepare thoroughly. These meetings should be requested well in advance to ensure they occur at the most beneficial time in your development process.

Key Benefits of Type B (EOP) Meetings

Engaging in Type B (EOP) meetings can provide several strategic advantages for your company:

• Regulatory Alignment: Gain clear and actionable feedback from the FDA, ensuring your development plan meets regulatory expectations and reduces the risk of setbacks.
• Informed Decision-Making: Use the insights from these meetings to make informed decisions about your phase 3 trial design, data collection methods, and overall development strategy.
• Proactive Issue Resolution: Identify and address potential issues early, preventing costly delays and increasing the likelihood of a successful submission.

How to Prepare for a Type B (EOP) Meeting

Preparation is key to making the most of your Type B (EOP) meeting. Consider the following steps:

• Define Clear Objectives: Clearly outline the goals of the meeting and the specific issues you want to discuss.
• Develop a Detailed Agenda: Prepare a comprehensive agenda that includes all relevant topics and questions, ensuring that the meeting covers everything you need to address.
• Gather Supporting Documentation: Compile all necessary data, study results, and other documentation that can support your discussion points and provide context for the FDA.
• Engage Key Stakeholders: Involve all relevant team members and stakeholders in the preparation process to ensure a well-rounded and informed discussion during the meeting.

Conclusion

Type B (EOP) meetings are a pivotal element in the successful development and approval of new drugs and biologics. By leveraging these meetings strategically, you can ensure regulatory alignment, make informed decisions, and proactively address potential challenges. Careful planning and thorough preparation will help you navigate these critical transition points effectively, bringing your innovative products one step closer to market approval.

Navigating the Path with a Type C Meeting: A Guide for Prospective Companies

As a forward-thinking company dedicated to the development and review of new products, engaging in a Type C meeting with the FDA can provide valuable insights and guidance at various stages of your journey. Unlike Type A and Type B meetings, Type C meetings offer a flexible platform to address a broad range of topics essential to your product’s advancement.

What is a Type C Meeting?

A Type C meeting is any meeting that doesn’t fall under the specific categories of Type A or Type B. This means it can cover a wide array of discussions between your team and the FDA’s Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER). Whether you need clarification on regulatory requirements, feedback on study designs, or advice on specific aspects of your product’s development, a Type C meeting can be tailored to your unique needs.

Scheduling Your Type C Meeting

To ensure a timely and efficient process, Type C meetings should be scheduled to occur within 75 days of the FDA receiving your written meeting request. If circumstances necessitate a meeting date beyond this 75-day window, the FDA will collaborate with you to identify the earliest mutually agreeable date.

Key Considerations for Type C Meetings

• Versatility and Scope: The flexible nature of Type C meetings means you can use them to address a variety of topics not covered under Type A or Type B meetings. This could include discussions on novel study designs, post-market surveillance plans, manufacturing issues, or any other development-related questions.
• Strategic Planning: Given the broad applicability of Type C meetings, it’s crucial to approach them with a clear agenda and specific questions or topics for discussion. This helps maximize the value of the meeting and ensures you receive targeted advice and feedback from the FDA.
• Collaborative Approach: Engaging in open and constructive dialogue with the FDA during a Type C meeting can help build a collaborative relationship, fostering a better understanding of regulatory expectations and facilitating smoother progress for your development program.

Advantages of Type C Meetings

By strategically utilizing Type C meetings, your company can benefit in several ways:

• Customized Guidance: Receive tailored advice on specific aspects of your product development that might not be covered in other types of meetings.
• Proactive Issue Resolution: Address potential challenges early, reducing the risk of delays and ensuring your development program stays on track.
• Enhanced Regulatory Clarity: Gain a clearer understanding of the regulatory landscape, helping you make informed decisions and streamline your path to approval.

How to Prepare for a Type C Meeting

Preparation is key to making the most of your Type C meeting. Consider the following steps:

• Define Your Objectives: Clearly outline the goals of the meeting and the specific issues you want to discuss.
• Develop a Detailed Agenda: Prepare a comprehensive agenda that includes all relevant topics and questions, ensuring that the meeting covers everything you need to address.
• Gather Supporting Documentation: Compile all necessary data, study results, and other documentation that can support your discussion points and provide context for the FDA.
• Engage Key Stakeholders: Involve all relevant team members and stakeholders in the preparation process to ensure a well-rounded and informed discussion during the meeting.

Conclusion

A Type C meeting is an invaluable tool for companies looking to navigate the complex landscape of product development and regulatory approval. By leveraging this opportunity, you can gain critical insights, address potential issues proactively, and build a strong, collaborative relationship with the FDA. With careful planning and clear objectives, a Type C meeting can significantly enhance your development strategy and bring you one step closer to achieving your product goals.

Strategizing with a Type D Meeting: A Guide for Prospective Companies

As a company dedicated to innovative product development, timely and precise feedback from the FDA can be pivotal in navigating key decision points. A Type D meeting is designed for this very purpose, focusing on a narrow set of issues that are crucial for advancing your program efficiently.

Understanding Type D Meetings

A Type D meeting is a targeted discussion with the FDA, typically addressing one, but not more than two, specific issues along with associated questions. This type of meeting is ideal for obtaining timely feedback on critical points that can significantly influence your development path. Here’s what you need to know about the scenarios that warrant a Type D meeting:

• Follow-Up Questions Post-Meeting: If a new issue arises after a formal meeting that goes beyond simple clarification, a Type D meeting can address this.
• Narrow Issues with Limited Questions: When you need the FDA’s input on a specific, narrow issue, you can present a few associated questions (typically three to five).
• Innovative Development Approaches: For general questions about novel development methods that don’t require detailed, extensive advice, a Type D meeting is appropriate.

Scheduling and Preparing for a Type D Meeting

To ensure an efficient process, Type D meetings should focus on no more than two topics. If your discussion requires more extensive input or covers multiple complex issues, a Type C meeting is more suitable. Additionally, if the topics require input from more than three disciplines or divisions within the FDA, the meeting request will be converted to the appropriate type, either Type B or Type C.

Examples and Scenarios for Type D Meetings

Here are some practical examples where a Type D meeting would be beneficial:

• Innovative Trial Designs: Seeking input on a specific aspect of a complex or innovative trial design, such as an innovative approach for pediatric studies.
• Data Presentation Questions: Clarifying how to present data effectively following a pre-BLA/NDA meeting.
• New Ideas Post-Type C Meeting: Addressing specific follow-up questions about new concepts that emerged from a Type C meeting.

Key Considerations for Type D Meetings

• Precision and Focus: Limit your discussion to one or two specific issues to make the most of the Type D meeting format.
• Avoiding Redundancy: Instead of requesting multiple Type D meetings in quick succession, consider whether a single Type C meeting might better address your needs comprehensively.
• Scope and Complexity: If your issues are broad or require input from multiple FDA divisions, be prepared for your meeting request to be converted to a more appropriate type, such as Type B or C.

Benefits of a Type D Meeting

Engaging in a Type D meeting can provide your company with several strategic advantages:

• Timely Feedback: Receive prompt and focused guidance on critical issues, helping you make informed decisions quickly.
• Clear Direction: Clarify specific aspects of your development plan, ensuring alignment with FDA expectations and reducing potential delays.
• Focused Dialogue: Benefit from a concentrated discussion on pivotal points without the broader scope of other meeting types.

How to Prepare for a Type D Meeting

Preparation is crucial to maximizing the benefits of a Type D meeting. Follow these steps:

• Identify Key Issues: Clearly define the one or two issues you want to discuss, along with the specific questions you need answered.
• Develop a Precise Agenda: Create a detailed agenda that focuses on your narrow set of topics, ensuring a productive meeting.
• Gather Relevant Data: Compile any necessary data, study results, or other documentation that supports your discussion points.
• Engage Relevant Team Members: Involve key stakeholders in the preparation process to ensure all relevant perspectives are considered during the meeting.

Conclusion

A Type D meeting is a valuable tool for companies seeking timely and specific feedback from the FDA on crucial issues. By strategically leveraging these meetings, you can navigate key decision points with greater clarity and confidence. Proper planning, a focused agenda, and a clear understanding of the meeting’s scope will help you make the most of this opportunity, advancing your development program efficiently and effectively.

Leveraging INTERACT Meetings for Early Development Success: A Guide for Pharmaceutical Companies

As a pharmaceutical company pioneering novel drug or biologic therapies, you know that early development is fraught with unique challenges. An INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting with the FDA is an invaluable opportunity to address these challenges head-on, ensuring a smoother path toward your Investigational New Drug (IND) application and subsequent clinical trials.

Understanding INTERACT Meetings

INTERACT meetings are specifically designed for novel products and development programs encountering unprecedented hurdles in early development, well before filing an IND or holding a pre-IND meeting. These meetings focus on resolving critical questions related to IND requirements, such as:

• Design of IND-Enabling Toxicity Studies: Discussing appropriate species, endpoints, and other parameters for preclinical studies.
• Complex Manufacturing Technologies or Processes: Addressing issues with innovative manufacturing techniques and processes.
• Development of Innovative Devices: Exploring the integration and development of new devices used in conjunction with your drug or biologic.
• New Approach Methodologies (NAMs): Implementing advanced methodologies that might otherwise delay your product’s progression to clinical trials without early FDA input.

To request an INTERACT meeting, you must have selected a specific investigational product or a defined product-derivation strategy intended for evaluation in clinical studies.

Key Topics for INTERACT Meetings

When preparing for an INTERACT meeting, consider addressing the following key topics:

• Novel Product Challenges: For products with unique challenges and no existing FDA guidance, these meetings provide a platform to seek regulatory input that cannot be referenced from existing literature.
• Pre-IND Preparations: Discuss crucial pre-IND issues such as:
  • Preclinical Models and Toxicology Studies: Choosing appropriate models and designing necessary studies for novel drug platforms.
  • Chemistry, Manufacturing, and Controls (CMC) Issues: Developing testing strategies to demonstrate product safety adequate for first-in-human studies.
  • Proof-of-Concept and Pilot Studies: Designing initial studies to support the administration of an investigational product in clinical trials.
  • First-in-Human Trial Recommendations: Receiving guidance on designing trials for target populations with no prior precedent or guidance.
  • Early-Stage Development Advice: Obtaining recommendations for further development when dealing with limited data collected outside the U.S. IND framework.
  • Additional Agreed-Upon Topics: Any other relevant topics that you and the FDA agree to discuss.

Strategic Benefits of INTERACT Meetings

Engaging in an INTERACT meeting offers several strategic benefits:

• Timely Regulatory Feedback: Gain early insights from the FDA, helping to navigate regulatory expectations and avoid potential delays.
• Proactive Issue Resolution: Address novel and complex issues early in the development process, minimizing risks and setting a clear path forward.
• Enhanced Development Strategy: Incorporate FDA recommendations into your development plans, enhancing the robustness and viability of your approach.

How to Prepare for an INTERACT Meeting

To make the most of your INTERACT meeting, thorough preparation is essential. Here’s how to get ready:

• Define Specific Objectives: Clearly outline the goals of your meeting, identifying the specific challenges and questions you need to address.
• Prepare a Detailed Agenda: Develop a comprehensive agenda that includes all relevant topics and questions, ensuring a focused and productive discussion.
• Compile Supporting Data: Gather all necessary data, including preclinical study results, manufacturing details, and any other relevant information to support your discussion points.
• Engage Key Stakeholders: Involve relevant team members and stakeholders in the preparation process to ensure a well-rounded and informed dialogue during the meeting.

Conclusion

INTERACT meetings are a critical tool for pharmaceutical companies developing novel therapies. By leveraging these meetings, you can proactively address early development challenges, align with regulatory expectations, and streamline your path toward clinical trials and eventual product approval. Careful planning and strategic engagement with the FDA will help you navigate the complexities of early-stage development, bringing your innovative products closer to benefiting patients.

We look forward to discussing your needs with you!