In-Brief:
- Medical writers must be subject matter experts of the regulatory control inside and out and know the drug under study in clinical research.
- To prepare a successful NDA(New drug application), a medical writer should know all the regulatory submissions basics.
- Pepgra provides you with essential tips for a medical writer to prepare a successful NDA and provides regulatory writing services.
Introduction:
Medical writing includes writing scientific documents of different types, with regulatory and research-related papers, disease or drug-related and promotional literature, publication articles like journals, manuscripts and abstracts, essential content for healthcare sites, health-related publications or news articles. The scientific data in these documents need to be accessible to suit the target audience’s level of understanding, namely, patients or the general public, physicians or the regulators. Medical writers require an understanding of the medical concepts and terminology, knowledge of relevant guidelines regarding the structure and contents of authentic documents, and good writing skills. They also need to be familiar with searching medical literature, understanding and presenting research data, document reviewing, and editing and publishing requirements. Many resources are now accessible for medical writers to regularly get vital training in medical writing science and art and regularly upgrade their knowledge and skills. The demand for the medical report is growing gradually in pharmaceutical and healthcare communication marketplace. Medical writers can work individually or active as full-time professionals.
Tips for a medical writer to prepare a successful NDA
It’s never too early to start your NDA preparation.
It would help if you began to think about your eventual NDA( New Drug Application) from the moment you start planning for your Pre-IND meeting and IND submission, and well before you have dosed a single patient. For instance:
- What is the most suitable regulatory path?
- What are clinical trials needed for the NDA and product label to be supported?
- Do you plan to seek expedited growth and expedited review?
- What is production information needed for the NDA?
- To help your application, do you need long-term toxicology/carcinogenicity studies?
- What needs to be outsourced?
All these questions should be front and centre as early as possible in your mind. Even though your NDA submission seems far off shortly, early preparation will make the difference between smooth sailing and rough seas.
Start assembling your NDA
Far too often, sponsors wait to start compiling their NDA until late in production, which can place undue pressure on resources and timelines. Note, each piece of the NDA you can finish and “put on the shelf” is one bit less that you have to think about later. You can relax a little better as the submission date approaches by knowing what elements can be accomplished early and then proactively completing those assignments during medical writing in clinical trials.
In most cases, by the time the drug reaches the clinic, a significant portion of the nonclinical program will be completed. All of this information can be explicitly pulled into the NDA’s related modules and incorporated as other studies become final. On the clinical side, as soon as you can, you should start reviewing your data and preparing your clinical research reports (CSRs). Before the research is complete, you can even start on the report shell. You can then collect the rest of the components and collect all the required approval signatures until final data is available. Analyses have been carried out using regulatory medical writing in clinical trials. When the time comes to colonize the NDA clinical overview pages, completing these activities would also encourage performance.
Know the related laws and regulatory guidelines
The FDA review division must manage your application, and for NDAs in general, to understand the applicable laws and regulatory guidelines that relate to your specific program. Although rules are legally binding, documents of advice are not in regulatory writing. However, guidance documents include the regulators’ latest thinking, reviewing the NDA (and hopefully approve it). Therefore, it should be done with caution, reason, and consultation with the FDA’s relevant review division to deviate from these guidelines.
Use standardized templates
When you start writing your IND, make sure you use uniform models and that a standard style guide regulates all authorship. To put together a masterful submission, you don’t have to have a fancy eCTD template kit, but you can make sure your submission documents conform to a standard format and style wherever possible. The same grammatical, punctuation, numbering, abbreviation, and text conventions should be practical by all writers working on the submission and should understand how to preserve the dignity of the underlying document’s formatting and styles.
Because of all the data and scientific weight in the submission, this may seem like a minor detail. Still, a polished, well-written, regularly formatted application package that conforms to current regulatory document requirements goes a long way to the success of a submission.
Enter your study data
To get all your early-phase data entered, queried, cleaned, and locked, do not wait until Phase 3. It will save many headaches, later on, to get an early start on data management and free up time to emphasis on other tasks as the NDA submission date approaches. If the data is locked, you can start producing study-specific tables, listings, and figures to help study reports and summaries inside the NDA.
Request a Pre-NDA meeting
Your primary late-stage opportunity to get feedback from the FDA on your request is the Pre-NDA meeting. As such, you must put a lot of thought into the topics of discussion you want to raise and ensure that the questions you pose are straightforward, well-supported, and placed to allow the FDA to make a meaningful response. Suppose any particular elements of your program or submission may affect successful filing or review and have not been addressed through previous interactions. In that case, it is now time for the FDA to discuss them. Prepare your claims and your “Plan B” well in advance and consider the possible impacts of both of these on your submission’s content and deadlines from medical writing solutions.
Establish realistic timelines for every aspect
Communicate deadlines and obligations, and follow-up often, to all relevant stakeholders and participants. The overwhelming amount of information that needs to be obtained, processed, interpreted, and shared inside the NDA should be careful in the timelines. Establishing an NDA “tracker” is one of the easiest ways to do this. The most important thing if the tracker is part of a sophisticated software package specifically designed for regulatory submissions, a simple spreadsheet, must contain some crucial and actionable submission information. It requires listing constituent documents with sufficient granularity, the parties involved, each document’s current status, and the due dates.
Allow at least a month for publishing your submission
Publishing timelines are often looking at as something that can be dense if “more critical” tasks such as authoring or scientific review take longer than planned. However, it can sometimes cut to publish timelines, mainly if study reports and different NDA parts are being firm up as you go. It is important not to underrate the vast amount of effort and time involved in setting up a proper submission. Even with leading-edge technologies, publishing needs a considerable amount of time, not to mention quality control activities and final validation of the request, to ensure consistent document formatting, hyperlinking, bookmarking, and arrangement within the eCTD system. Publishing timelines should be compressed with care, prospectively wherever possible, and in close contact with the publishing team at all times.
Take the big picture to guarantee a good submission
Take a minute to consider the picture of what it takes to confirm a good proposal, whether this is your first NDA or just one of many that you’ve done. Pulling an NDA together is a vast undertaking that takes considerable time and effort to complete an investment. Consider your organization or institution’s resources and skills and the internal ability to execute the necessary tasks in your desired timelines, and then make a reasonable assessment of whether additional support is required.
Conclusion:
Pepgra offers several scalable services to help our clients yield high-quality, compliant NDA submissions. Suppose you are thinking of outsourcing your whole NDA(New Drug Application). In that case, you need a partner to assist with publishing and submitting. Even if you have just one or two papers that may benefit from an accomplished clinical pharmacology expert’s examination, Pepgra will help regardless of your need along with Regulatory Writing Service in Clinical Research.
References:
- Lies, R. L. (1984). Preparing the Nda Summary: How to, How Not to and why. Clinical Research Practices and Drug Regulatory Affairs, 2(3), 259-271.
- Schwarz, S. W., Dick, D., VanBrocklin, H. F., & Hoffman, J. M. (2014). Regulatory requirements for PET drug production. Journal of Nuclear Medicine, 55(7), 1132-1137.
