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.

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.

What 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.