The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables for each. Beginning with R&D, you will have to ensure that your product corresponds with the FDA’s definition of a drug product. Next, it is advised that you conduct sufficient testing to get a baseline understanding of how your product works, what its intended use is, and other product specifications. Once you have completed this first step, you are ready to embark on the drug development journey...

1. Understanding the Drug Development Process
By: Madison Wheeler
The FDA’s process for drug development can be a lengthy, and often expensive,
commitment. If you are developing a new drug product from the beginning, it is critical that you
understand the phases of the development process and the deliverables for each. Beginning with
R&D, you will have to ensure that your product corresponds with the FDA’s definition of a drug
product. Next, it is advised that you conduct sufficient testing to get a baseline understanding of
how yourproductworks,whatitsintended useis, andother productspecifications. Onceyou have
completed this first step, you are ready to embark on the drug development journey.
Preclinical research is the first phase after the R&D of a drug product. This phase is often
considered the most critical since it is where researchers determine if the drug has the potential
to cause harm, also known as toxicity, before moving on to clinical research.These studies are not
typically very large and can be done either in vivo or in vitro, but regardless of how you conduct
your preclinical research, it must be done in compliance with good laboratory practices (GLP).
The GLP regulations set the standard for parts of the research such as written protocols, study
reports, personnel, and facilities involved with the research.1
After preclinical research comes the most daunting aspect of drug development, clinical
research. This is the part of the journey where drug developers typically feel the real pressure of
the regulatory requirements because you are starting to study your drug in humans. After you
have submitted your Investigational New Drug (IND) Application to the agency and determined
yourclinicaltrialobjectives (likecontrol groups,how thedata willbe analyzed,how long thestudy
will last, etc.), you are ready to start Phase I of your clinical trial. Clinical trials typically follow a
Phase I, Phase II, Phase III cadence, with the first being small-scale and progressively getting
larger as you progress through the phases.2 Clinical trials are not brief endeavors and can span
upwards of 10-15 years depending on the drug. Any drug developer must understand the time
commitment involved with clinical trials.
Although the completion of a clinical trial can feel like a relief to drug developers, there
are still more steps to take along the journey to get their product on the market. Once you have
compiled all of your preclinical and clinical research for your product, it is time to file a New Drug
Application (NDA) withtheFDA. The FDA willneed to see all yourresearch data,from preclinical
through Phase III trials. Additionally, you need to submit proposed labeling, drug abuse
information, directions for use, and any data from studies that may have been conducted outside
of the US. In short, the hard work is not done just because the clinical trials are over.
1 FDA (Jan 2018) Preclinical Research retrieved on 01/24/2021 from: https://www.fda.gov/patients/drug-
development-process/step-2-preclinical-research
2 FDA (Jan 2018) Clinical Research retrieved on 01/24/2021 from: https://www.fda.gov/patients/drug-
development-process/step-3-clinical-research#The_Investigational_New_Drug_Process

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Assuming the FDA deems your NDA complete, meaning they don’t come back with
requests for additional information, the agency has six to ten months to decide on whether to
approve the drug. During this time, the FDA review team is analyzing every inch of your data,
traveling to clinical study sites to conduct inspections, and compiling the final package of your
drug which a senior FDA official will use to make the approval decision. Often, the FDA will
require additional information during this time, and may even require additional studies if the
clinical data is deemed insufficient.3
Once all the data has been presented, all the agency’s questions answered, and assuming
the safety andefficacy hasbeenproven, yourdrug is finally approved. Butstill, there is morework
to do. At this point, the FDA will want to work with you to develop prescribing information, or the
labeling of the drug. Once you have accurate labeling developed, congratulations - your product
is approved and ready for marketing! Although drug development canbe an enormous time and
resource commitment, it is a rewarding accomplishment to get a drug product through the FDA’s
process. EMMA International has helped several firms through various stages of the drug
development process, from R&D all the way through NDA approval. Contact us at 248-987-4497
or info@emmainternational.comtoseehow wecansupportyourteam getthrough theFDA’sdrug
approval process.
3 FDA (Jan 2018) FDA Drug Review retrieved on 01/24/2021 from: https://www.fda.gov/patients/drug-
development-process/step-4-fda-drug-review