Chemistry Reference
In-Depth Information
While the cost of successful development and commercialization of a new drug
increases significantly with the amount of time expended in years, there is also a
substantial increase in costs from the beginning of the Clinical Phase III trials to
the NDA submission, and a phase approach to method development and validation
is one way to reduce costs in drug development. Figures have placed the cost of drug
development at anywhere from $897 million to upward of $1.7 billion spread out
over 8 to 12 years [4,5]. Phased-in or phase-appropriate method development and
validation can save a firm time and expense by not performing needless procedures
too far in advance. The goal, of course, is to reduce these time requirements as much
as possible, and consequently the cumulative costs involved.
In addition to being a GLP/GMP regulatory requirement, a validated method
ensures reliable results, reducing the necessity of repeating expensive studies. Once
the drug goes to market, there may be reasons to develop simpler, more robust, more
reproducible, faster, cheaper, and easier-to-perform methods, sometimes for cost
efficiency and effectiveness or in order to take advantage of new technology. In these
instances, when the expense is justified, methods may need to be revalidated.
1.3 FdA HIerArcHy And orgAnIzAtIon
The pharmaceutical and biotechnology industries are two of the largest and most
rapidly growing industries in the world. Some of the most productive and profitable
companies in the world are pharmaceutical or biotech based, and their names have
become synonymous with big business. These companies are beholden to the FDA
from the initial IND application all the way through to the NDA and final market-
ing approval. The pharmaceutical industry is perhaps the most heavily regulated
industry in the world, and researchers from around the world look to the US FDA for
guidance on a regular basis.
The FDA's mission statement is: “… protecting the public health by assuring the
safety, efficacy, and security of human and veterinary drugs, biological products,
medical devices, our nation's food supply, cosmetics, and products that emit radia-
tion. The FDA is also responsible for advancing the public health by helping to speed
innovations that make medicines and foods more effective, safer, and more afford-
able; and helping the public get the accurate, science-based information they need to
use medicines and foods to improve their health” [6].
It is required of all pharmaceutical firms, no matter where they are located in the
world, to receive FDA approval for initial clinical studies, final clinical studies, and
NDAs before marketing their products in the United States. It is the US FDA, in the
end, that will decide which products are safe to enter clinical studies, which products
are justified in going to market, which products shall remain on the market, and to
deal with whatever problems may arise once a product has been on the market for
any length of time.
The FDA is an agency within the Department of Health and Human Services and
consists of eight centers/offices:
1. Center for Biologics Evaluation and Research (CBER)
2. Center for Devices and Radiological Health (CDRH)
