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September 16, 2021 Regulatory Affairs

Have an FDA Submission on Your 2021 To-Do List?


At the start of every year, we all have these grand plans of everything we plan to accomplish. It is a fresh start to really get stuff done and we have a full 12 months to do it all. However, priorities shift throughout the course of a year. We all get sidetracked and suddenly, it’s September and we find ourselves looking over those goals we set in January thinking some of them are impossible to accomplish with the limited amount of time that is left in the year.

Although some milestones may actually be impossible, others may seem near impossible, but with the right support, you can actually still accomplish those lofty goals you set for yourself and your team. The first that comes to mind for us are FDA meetings and submissions. Did you set a goal to submit an application to the FDA this year but haven’t made any progress toward actually submitting it yet? If so, you are probably thinking that is one of those items that could not possibly be achieved with less than four full months remaining in 2021. With the right regulatory experts guiding the way, you still have time to accomplish a number of FDA milestones, including:

  1. Pre-IND Meetings
  2. Orphan Drug Designation
  3. Fast Track Designation
  4. Breakthrough Therapy Designation

How to Submit a Pre-IND Meeting Request and Briefing Package in Less Than Four Months

If you are asking yourself if this is possible and realistic, the answer is yes. But, that is only possible if you are willing to put in a lot of hard work and make sure you have the best team of experts on your side.

If you are ready to tackle a pre-IND meeting and would like to begin before the end of 2021, here are some tips to help increase your chances of success:

  • Be prepared, knowledgeable, confident, thorough, and cooperative in your communication with the Agency.
  • Everyone has flaws, make sure you know what yours are. Take a step back and take an unbiased and unemotional look at your product. What do you see? That is exactly what the regulators will see. Being objective will allow you to be better prepared for the feedback you will get from the FDA.
  • Be honest with the Agency. The purpose of the meeting is to get useful, complete, and unambiguous information. The feedback you get from the regulators will only be as honest as the data you present.
  • Be serious when meeting with the FDA. It sounds like common sense, but you would be surprised to know that is not always the case. This is an important business meeting with real benefits and consequences; make sure it is treated a such.
  • Take great care when framing the questions in your meeting request, as this will be the basis of the discussion during your meeting. Make sure the questions are centered on your expectations and what you want to gain from the meeting.
  • Make sure you have the right people at the meeting. You don’t want to be missing someone important to the conversation, but you also don’t want to have anyone who is not necessary – it is important to strike the right balance.
  • Practice, practice, practice. You cannot be too prepared for your pre-IND meeting; the more practice you have, the better.
  • During the meeting, make sure you stick to the script you have practiced. Don’t include any off-agenda items, as the FDA will not entertain any surprises.

Can I compile and submit a successful orphan application to FDA before the end of 2021?

You bet you can. But like the feasibility of pulling off a pre-IND meeting in this timeframe, you have to be willing to put in the work.

FDA aims to review and respond to all Orphan Drug Designation (ODD) submissions within 90 days of receipt. With that being said, if you want your application to be reviewed before the end of the year, the window of time for submission is closing in quickly. However, with the right experts on your team, you can absolutely still accomplish this before the end of the year. Our team of regulatory scientists are exactly the experts you need. With countless submission under our belt, we know what FDA expects to see what how they expect to see it. Our regulatory submission consultants help take the guess work out of the equation, drastically increasing your chances of successful interactions with FDA.

What about Fast-Track and Breakthrough Therapy Designation requests?

Good news again – these are also possible to submit and get a response from FDA before the end of the year. But, yet again (you can probably guess what is coming next…) not without dedication, hard work, and a knowledgeable and experienced team of experts in your corner.

For both fast-track designation and breakthrough therapy designation requests, FDA aims to respond within 60 days of receipt. So, while there is a little more time for these types of submissions than for pre-IND meetings or orphan drug designation submissions, the clock is still ticking and the sooner these types of requests are submitted to the Agency, the greater your chances of hearing back before the end of the year and getting a favorable response.

Why does getting started sooner than later increase your chances of success? The sooner you start, the more time you have to submit your request before the window of opportunity closes for receiving feedback this year. With that being said, the more time you have to prepare your submission, the less likely you are to make careless mistakes. These careless mistakes that sometimes happen when trying to rush through your work can cost you both time and money. And at this point, these types of mistakes can cost your entire product’s future.

Our team of experts had extensive experience developing fast-track and breakthrough therapy designation requests for submission to FDA. We can help you avoid these “careless mistakes” that you may not realize you are making. We can help you prepare a successful submission the first time, saving you both time and money by avoiding costly errors.

Our team of regulatory consultants is made up of the best of the best. Our experts have a vast range of experience and bring a diverse set of capabilities to the table. However, our experts are not miracle workers and we cannot turn back the clock. After a certain time, it will not be feasible for us to ensure your applications will be reviewed before the end of the year. We are not at that point yet, but we are getting close. Don’t keep putting it off. Contact us today to learn how we can help you obtain successful interaction with the FDA before the end of the year.



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