The pre-submission team’s approach—streamlining made simple.

Expertise for a successful FDA submission.

By: Multiple Contributors

The pre-submission team’s approach—streamlining made simple.

Key Takeaways

  • Start by educating brand teams on the differences between pre-submissions and standard FDA submissions. This will enhance collaborative work by ensuring everyone understands the unique requirements and standards for each type of submission.
  • Set up a reference system to manage references with maximum efficiency. This system should ensure that only approved versions are used in submissions, preventing errors and improving the quality of the final submission.
  • Plan stakeholder meetings a year in advance to align processes and timelines. These meetings lay the groundwork for thorough planning, enabling all parties to understand expectations and deadlines well in advance.
  • Develop custom checklists for each project to ensure adherence to FDA regulations and Office of Promotion and Advertising Review (OPDP) requirements. These checklists serve as a guide, helping teams stay organized and focused on meeting all necessary requirements.

Navigating the intricacies of FDA pre-submissions can often feel like a daunting task. The process is complex, with stringent regulations and specific requirements that differ significantly from standard submissions. However, through strategic planning and effective management systems, it's possible to streamline this process, improve efficiency, and increase the likelihood of successful submissions.

In this blog post, we present four key strategies that can dramatically improve your pre-submission process. From educating brand teams on the nuances between pre-submissions and regular FDA submissions to implementing a foolproof reference system, planning stakeholder meetings well in advance, and developing custom checklists for each project, these strategies help ensure you stay on top of every detail.

So, whether you're grappling with your first pre-submission or looking to improve your existing approach, these strategies offer a comprehensive guide to enhancing your pre-submission process. 

1. Ensure marketers and agency partners understand the pre-submission process

The FDA Pre-Submission Program is a unique approach designed to facilitate more efficient and effective regulatory reviews of drug, biologic, and medical device submissions. Unlike regular FDA submissions for marketing approval, which take place after all testing has been completed, pre-submissions allow pharmaceutical companies to engage with the FDA early in the development process. The pre-submission program essentially functions as a collaborative problem-solving stage, while the regular submission serves as a final presentation of all the collected data.

Through the Pre-Submission Program, the FDA can provide preliminary feedback on testing protocols, clinical trial designs, and other crucial aspects of the submission. This information is invaluable to pharma companies, identifying potential regulatory or scientific issues at the onset and enabling them to be addressed before a formal submission is made.

It's important to underscore that regular FDA submissions and the Pre-Submission Program are not one and the same. They each operate with different timelines, rules, and requirements. And since pre-submissions are an optional step in the FDA submission process, it's common for pharma marketers to lack the knowledge or experience to go through pre-submissions successfully. 

That's why it's crucial to hire team members, allocate resources, or offer comprehensive training to ensure that marketing teams have a thorough understanding of pre-submissions. Developing a customized Standard Operating Procedure (SOP) and training program ensures everyone is aligned and well-prepared for the journey ahead.

Agency partners may also lack past experience in successfully navigating pre-submissions. However, the best pharma marketing agencies will be well-versed in this program and will bring best practices and innovative solutions developed through their work with other pharma or medical device clients.

2. Planning for FDA timelines

Building a successful pre-submission process requires careful planning and coordination. This could begin a year in advance, with initial stakeholder meetings to align on the processes and timelines. With an understanding of the brand's market tactics, the Brand Team can determine a readiness date well in advance of the FDA blackout date, setting the stage for the journey ahead.

At Aquent Studios, we firmly endorse an approach that integrates a specialized, dedicated pre-submission team working in tandem with the Brand Team. Such a pre-submission team is pivotal in bolstering a brand by offering invaluable guidance and proficiency to traverse the intricacies of submission processes. They diligently review and provide constructive feedback to refine the quality of submissions, thereby potentially conserving time and resources, which aids in mitigating the risks associated with submissions and saves time and money. In essence, the pre-submission team ensures all pre-submission checks are completed, amplifying the probability of a successful pre-submission and strengthening the brand's reputation.

As each pre-submission is different, the best approach to managing the process is a tailored approach. However, every pre-submission project involves extensive collaboration between the Brand Team, agency partners, and the FDA liaison. Regular weekly check-ins over the course of the year ensure all teams are aligned and adequately supported in preparing their submissions.

Feedback from the FDA liaison is an integral part of the process. The typical timeframe for implementing necessary changes based on this feedback ranges from a few days to a week unless it's a high-priority job requiring faster action. Timelines might be less stringent for new product launches, while recertification jobs follow different processes and timelines. 

Efficient review and turnaround of tasks are important factors in whether or not the team can stick to the overall project timeline. The Pre-Submissions Team should include a clear explanation of the end-to-end process along with a detailed timeline for all tasks. Unless a tactic is exceptionally complex, the team should aim for a 24-hour turnaround for all reviews, ensuring swift and effective project execution.

Managing promotional material timelines forms another critical aspect of the process. The timeline of FDA accelerated approval tactics is based on the scheduled regulatory review date or a date when a tactic needs to be in the market. Ideally, the average timeframe from when a tactic is approved for production by regulatory to when the pre-submission is sent to the FDA is about 2-3 weeks.

3. Develop a reference library

In preparing materials for FDA pre-submission, one significant challenge is efficiently managing multiple references. The marketing team has to meticulously review materials for proper file setup, annotations, referencing, and quality, all in accordance with stringent FDA guidelines. The FDA stipulates that each submission can only utilize one version of a reference, but content libraries often contain more than one version of a reference.

In order to solve the problem of multiple references, Aquent Studios developed a centralized, curated reference library, which includes core references. In addition, we established a dedicated Reference Steward Team charged with collecting references from various agencies, identifying a core reference, uploading it into the library, and educating all teams about the version they should use.

Today, we have a streamlined process for each client where multiple brands are supported with their reference needs, benefiting everyone involved in the process.

4. Utilizing comprehensive checklists for quality control

Adherence to FDA guidelines is of paramount importance in pre-submissions. To achieve this, we have developed comprehensive checklists based on the FDA liaison's requirements. These checklists are specially tailored for each project. For example, one of our clients has a vaccine in the pre-submission process, which necessitates specific annotations and references in their tactics.

These checklists have been instrumental in ensuring that all details, even those that might be overlooked due to a focus on the bigger picture, are addressed. This meticulous attention to detail is vital for gaining liaison approval as we navigate the path of stringent FDA requirements. Our process is designed to align with the instructions provided by our liaison for the Office of Promotion and Advertising Review / Advertising and Promotional Labeling Branch (OPDP / APLB).

Agencies and job owners often work on multiple tactics simultaneously, ranging from 10 to 20 or more at a time. These tactics can be pre-submission, branded, or unbranded, each requiring specific formatting, functional annotations, metadata changes, and unique notes required by the FDA. These standards are not typically necessary for regular jobs but are crucial for pre-submission tactics.

The implementation of these checklists in daily operations assists agencies in ensuring the fulfillment of all job requirements. Moreover, it facilitates a synchronized workflow between the organizations, agencies, and job owners throughout the review process by offering real-time updates on each task's progress. This systematic approach helps guarantee no detail is missed, while promoting transparency and effective communication among all parties involved.

In addition to the checklists, we utilize a project management tool as a one-stop platform for tracking, scheduling tasks, monitoring status changes, and maintaining organization. It provides our teams with direct access to tactics, medical-legal review (MLR) times, and scheduling.

Through this tool, we can monitor pre-submissions, conduct quality checks, and download tactics for review. Furthermore, it enables us to oversee the assembly of tactics, where job owners and agencies input their material, and reviewers add their feedback.

The combination of checklists, collaboration, and this project management tool has led to a significant decrease in recertification rates, demonstrating the effectiveness of this approach.

Proceed with confidence 

By implementing these four strategies, pharmaceutical companies can significantly improve their pre-submission process. Remember, the key to successful submissions is thorough preparation, attention to detail, and effective collaboration among all stakeholders. With these strategies in place, you're well on your way to making your next FDA pre-submission more streamlined, efficient, and ultimately, successful. Stay informed, stay organized, and you'll navigate the complexities of FDA pre-submissions with confidence.

About the Author

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Nancy Vaidya

Director, Strategic Account Operations

Nancy takes pride in being an employee at Aquent for almost 18 years.  During her tenure, she held multiple assignments at Pfizer, Johnson and Johnson and is currently the Director of Strategic Account Operations on the Merck engagement.  She is an excellent troubleshooter and an “Out of the Box” thinker.  She was instrumental in identifying new business initiatives which contributed to the significant revenue growth for this account.  While managing the operations and execution of the teams, her process driven thinking led to the creation and growth of several teams supporting the therapeutic areas of oncology and vaccines.  Nancy's expertise in reporting, analyzing and developing solutions has been a major contributor to Aquent's success at Merck.

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Bailey Fucanan

Pre-Submissions Team Lead

Bailey Fucanan is an award-winning communications professional who has worked with various clients writing, editing, crafting public relations campaigns, and managing teams and projects. She joined Aquent as a reference steward after a stint as an editor/proofreader at an educational assessment organization. She soon moved into pre-submissions and has been a team lead for nearly three years. Bailey enjoys photography, travel, reading, and cycling on her Peloton.

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Susan Boody-Hess

Pre-submission Team Lead

A dedicated team leader with a passion for delivering high-quality and timely projects. Since joining the Aquent Pre-submission Team for Oncology in 2018, Sue has leveraged my leadership and training experience to conduct extensive coaching of team members to expand their skill set. She has trained and mentored a strong pool of Aquent Associates, enabling them to advance to new job opportunities within client engagement. Prior to joining Aquent, she had over 30 years of leadership, operational and training responsibilities in the retail industry.

 


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