Blog & Resources Camargo Blog June 27th, 2018

What Clinical Studies Are Needed for a 505(b)(2) Drug Development Project?

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What Clinical Studies Do I Need to Run for my 505(b)(2) Drug Development Project?

Read the transcript of the video podcast below or click play to watch the discussion:


One of the first things we are asked when we get a call from a prospective client is when they are trying to find out what clinical studies do they need to run for their 505(b)(2) development program. The CEO of the company wants to know what the project is going to cost and how long it will take. They want to know the clinical studies they will have to do to get it approved. They have looked at the FDA website and the FDA guidances as a rough-cut approximation of what they’re going to need. But that is not enough, in our experience. Why is that not appropriate? What is it that Camargo can do to help them to know the cost and timeline for a 505(b)(2) development program?

Dr. Stevens:

For 505(b)(2) drug development, it is very important to know upfront what type of information is in the public domain that can be relied upon for a specific project. While the guidances give a general stroke of the type of studies that need to be done, they don’t tell you if they need to be done, and if you can have published literature that supports not duplicating efforts of the efficacy or safety that needs to be studied. When you are looking to develop a 505(b)(2) development product, it’s very important to know what type of information you are going to rely upon. That is what helps design the studies that are needed.


You mentioned that public information tells us whether the studies do actually need to be run. Tell us about how you use the public information to inform on the study design itself.

Dr. Stevens:

Public information gives you information in terms of the safety of the product. How many people were exposed? In terms of the public information, it gives you an idea of the exposure over time of the drug substance you are looking to develop. The FDA may take that data into consideration in terms of the size of the safety database that is needed.


If you have substantial safety data, and you can use it, the study design will allow you to have a less costly and a faster study. Right?

Dr. Stevens:

That is right. Because you may not have to look at the exposure over time. You could cut down the study by six months or so. The cost is also that you are not collecting additional patients just to look at their safety. You are really looking at efficacy data.


We know that some of the guidances are out of date. Sometimes the guidances that are published take time to come up with a new and updated guidance. When a client looks at the guidance, they may be out of date. What can we offer those clients in terms of the information?

Dr. Stevens:

Since drug development information changes rapidly over time, what we can do to help with the drug development is to be able to give advice in terms of what the FDA is looking at currently. We are at the FDA regularly, almost weekly, and we have up-to-date information that supersedes what the guidances may have as a general guidance for development.


In summary, the reason why you can’t rely on the FDA guidances for 505(b)(2) drug development:

1) The published guidance may be outdated. Camargo may have more updated information than what is on the guidance page.

2) You may not have to run those studies at all depending on the public information.

3) The studies suggested in the published guidance may be too big, too large, too long based upon the public information that is available.


Contact us at Camargo to learn more about clinical studies appropriate for your 505(b)(2) development project.

Categories: 505(b)(2) Development

Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights