New Drug Application (NDA)

After all of the clinical trials mentioned above are completed, then the company analyzes the data and files an NDA with the FDA if the data successfully demonstrates safety and effectiveness. The NDA is usually about 100,000 pages or more and contains all of the scientific information that the company has gathered. By law, the FDA is allowed six months to review an NDA. In most cases the time from first submission of an NDA and final FDA approval usually exceeds six months. The average NDA review time for new molecular entities approved in 1992 was 29.9 months.


Once the FDA approves the NDA, the new medicine becomes available for physicians to prescribe. The company must continue to submit periodic reports to the FDA, including any cases of adverse reactions and appropriate quality control records. The FDA requires some medicines to have additional studies (Phase IV) to evaluate the long-term effects of the drugs.

After reading the above steps in the development of a new drug, it is not hard to see why drugs cost so much when they finally do get to our medicine cabinets. Many people in the pharmaceutical industry  are looking for ways to expedite the development of drugs and to decrease some of the money put into this development. One resource that is being utilized in the development of new drugs is bioinformatics. The Bioinformatics industry is still in its infancy stages, but it has started to change the way drug development has emerged since 1998. Bioinformatics helps to take some of the fragmentation out of the development of new drugs. Most drug development has been more or less by trial and error. Bioinformatics uses information technology to be able to develop large databases and algorithms which help in the development of new drugs.

An example of this is the European Bioinformatics Industry (EBI). The EBI serves researchers in molecular biology, genetics, medicine and agriculture from academia. The EBI also serves the agricultural, biotechnology, chemical and pharmaceutical industries. The EBI is able to serve these researchers and industries by building, maintaining and making available databases and information services that relate to molecular biology. The EBI also carries out research in bioinformatics and computational molecular biology. More information about EBI can be obtained from going to their website which is as follows: Â

For those of you who are interested in learning more about the pharmaceutical pipeline (an industry term used for the research and development process of creating new drugs), Searle’s Research and Development Department has a web site for you. This web site actually takes you step by step in the development of a new drug. The web site is as follows:  On this web site you can select from a few diseases such as cancer, cardiovascular related diseases, or arthritis as your primary target to be able to develop a new drug for.Â

If the virtual formulation of a new drug is not enough, then all of you are invited to visit the following site from John Hopkins University, in which you can actually be the participant in a research study. Most of these studies involve the development or refinement of drugs but some don’t involve any drugs at all.  There is also a monetary incentive involved with some studies. The web site is as follows:  Due to geographic limitations, it may be difficult to be able to attend the clinic visits that are required. To be able to find out research studies in your local area, check with the nearest teaching/university based hospital and I am sure they would be more than happy to get you involved in a research study.

In summation, it is easy to see the vital role that chemical engineers play in the development of new drugs. It takes the knowledge and skill of many disciplines to formulate a new drug. When all of these discipline work together, it helps to expedite the formation of new drugs to help alleviate the effects of diseases for people around the world.Â

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