FDA Meeting Consulting Services
Planning & Executing Successful FDA Meetings
To achieve your goals in an FDA Meeting, the interaction must be carefully planned and flawlessly executed, leaving the regulatory Agency with a good impression of your product and company. This requires expert guidance from professionals who have prior regulatory experience and know the appropriate time to request a meeting, what is needed to prepare the necessary paperwork, what to expect when meeting with the FDA, and what steps should be taken post-meeting. To the best extent possible, any meeting with FDA should end in clarity. Our extensive experience managing communications with the various worldwide regulatory authorities can help reduce time to market and conserve patent life.
ProPharma: The World's Leading FDA Meeting Consultants
ProPharma's Regulatory Sciences team takes a unique approach to FDA Meeting preparation and execution, which has allowed us to establish a long-standing track record of success with the Agency. On average, our team meets with FDA on a weekly basis, and has conducted 1,000s of successful interactions with FDA over the last 40 years.
FDA Pre-IND Meeting Consultants
You have been planning for this moment for so long, and it is finally here. You’re ready to begin testing your drug in humans but are not sure that the design of your studies is valid, or maybe you’re looking for confirmation that your rationale is sound. You need to attend a Pre-IND Meeting with the FDA. The Pre-IND Meeting will allow you to communicate with the FDA early in the process, getting feedback on your drug development program before moving forward.
End of Phase 2 (EOP2) Meetings
Following your Phase 2 clinical trials, you will need to review and obtain agreement from the FDA on your study designs for Phase 3. This is the purpose of the End of Phase 2 (EOP2) Meeting with FDA, in which you’ll need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
During this meeting, FDA will determine whether it’s safe to proceed to Phase 3. They will evaluate your Phase 3 plans and protocols along with your existing studies to assess effectiveness, and they’ll note if any additional information is necessary to support the marketing application. The End of Phase 2 Meeting is a critical milestone in your development program, so it’s important to prepare to make sure you leave with plenty of helpful feedback.
FDA Advisory Committee Meetings
We have pioneered a unique marketing-based approach to FDA Advisory Committee Meetings to get you through this high-stakes interaction. Each Advisory Committee is different and has specific needs and concerns, which should be kept in mind as you discuss your product.
After learning about key issues in your product’s history and identifying critical issues in your current application, ProPharma will create a strategy for your meeting that is predicated on concerns likely to be raised by the FDA Advisory Committee, and the data necessary to address them. With this strategy in place, we will help you to prepare a slide presentation that presents all information in a complete, understandable, and simple manner. Since most Committee members will review this information before the meeting, we must make it easy for them to understand why approval is rational. Next, we will make sure all participants are prepped for the meeting by conducting a rehearsal to train the speakers. Finally, we will attend the meeting with you, along with select Key Opinion Leaders (KOLs), providing data and presentations as needed during the meeting.
FDA Pre-NDA Meeting Consultants
Thousands of hours and millions of dollars have gone into assuring a safe and effective product. The next and final step is Food and Drug Administration (FDA) approval and the key to achieving this is a perfectly executed Pre-NDA Meeting.
If you’re not sure where to start, we’ll explain everything you need to know about Pre-NDA Meetings with the FDA. For additional guidance with your New Drug Application, you can also contact our expert NDA consultants to help navigate the regulatory landscape.
Are you ready to achieve your regulatory goals?
Contact us today to learn about our 40-year track record of success with FDA and how we can help you get to the next regulatory milestone.
Pre-IND Meeting Preparation & Execution
Pre-IND Meeting Planning
ProPharma will guide you through the entire Pre-IND process – from submitting the initial FDA meeting request and supporting briefing document through preparing for and executing the meeting. Our goal is to help you meet this critical milestone.
Types of INDs
INDs fall into two categories, commercial INDs and research INDs:
Commercial IND: Commercial INDs are used when the Sponsor intends to bring the drug to the open market. This means commercial INDs can apply to drugs created by non-profit groups who intend to eventually put the drug on the open market. The application process and timeline for a Commercial IND is much longer and more complex than for a Research IND.
Research IND: Research INDs are used when the intention is to prove efficacy for a new indication of an already approved drug. Research IND applications are submitted by physicians, and with a process that is less complex than Commercial INDs. For example, Research INDs typically involve fewer investigators and are often done at a single testing site.
How to Submit an IND Application
Your IND application will request authorization from the 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. The requirements for an IND submission are complicated and can be hard to understand. For example, Commercial IND applications must be submitted through the FDA’s Electronic Submissions Gateway, while Research IND applications can be submitted in paper form to the relevant address. This is just one example of the complexities within the IND application and submission process.
As such, working with an experienced IND consultant helps to ensure you’re equipped and on track. ProPharma will work with you to make sure your IND application meets the FDA’s stringent IND filing requirements and contains all the necessary components.
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, we will carefully review the IND application, and our staff will provide you with a final copy that is FDA ready. The IND application will go into effect 30 days after the FDA receives the application (unless subject to a clinical hold), or earlier if the agency notifies the Sponsor that clinical trials can begin.
Frequently Asked Questions
Who is Eligible for an End of Phase 2 Meeting?
The EOP2 Meeting with the FDA is typically for Investigational New Drugs (INDs) that involve new molecular entities or major new uses of marketed...
Read MoreWho is Eligible for an End of Phase 2 Meeting?
The EOP2 Meeting with the FDA is typically for Investigational New Drugs (INDs) that involve new molecular entities or major new uses of marketed drugs. However, a Sponsor of any IND may request an EOP2 Meeting with FDA in preparation for Phase 3.
Read LessWhen Should the EOP2 Meeting Occur?
As the name implies, the EOP2 Meeting should occur at the end of Phase 2 clinical trials. Furthermore, the meeting should occur before serious resource...
Read MoreWhen Should the EOP2 Meeting Occur?
As the name implies, the EOP2 Meeting should occur at the end of Phase 2 clinical trials. Furthermore, the meeting should occur before serious resource commitments are made towards Phase 3. However, the EOP2 Meeting should not delay the transition from Phase 2 to Phase 3, which is why planning and preparation are critical.
Read LessWhy is EOP2 Meeting Preparation Important?
Before you can move to the next clinical phase, advancing your product's development and getting closer to obtaining FDA approval, you must prepare for and...
Read MoreWhy is EOP2 Meeting Preparation Important?
Before you can move to the next clinical phase, advancing your product's development and getting closer to obtaining FDA approval, you must prepare for and conduct a successful EOP2 Meeting with the Agency which ends in FDA agreeing that it is safe to continue to Phase 3 clinical trials.
ProPharma will work diligently with you to prepare for and conduct a successful EOP2 Meeting, helping ensure you get the green light from FDA to proceed with your product's development.
Read LessWhat is the Purpose of the Pre-NDA Meeting?
A Pre-NDA Meeting enables Sponsors and the FDA to ensure your New Drug Application (NDA) submission is well-organized and set up for success. The Pre-NDA Meeting should generally occur no less than 60 days before the submission date. Prior to the meeting, Sponsors should prepare for typical Pre-NDA Meeting questions over areas such as the formatting of the submission and inquiries regarding the evidence of effectiveness. During the Pre-NDA Meeting with the FDA, the Sponsor will discuss the format and content of the anticipated NDA, with a specific focus on the presentation of the data that will be submitted.
ProPharma NDA consultants specialize in various disciplines and stay abreast of changing trends and current events. In short, we bring a unique and extensive range of knowledge and skills to the table, which is what you need to achieve a successful Pre-NDA Meeting and NDA submission.
The World's Leading Regulatory Consultancy
Interested in learning how we can help with your regulatory needs? Contact us today to learn about our track record of success with the regulatory agencies over the last 40 years and discuss how we can help you get to the next regulatory milestone.
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