For this week discussion, open this arThe traditional route of drug approval is to first develop a treatment, conduct pre-clinical animal and human trials, and then submit a New Drug Application (NDA) for FDA consideration. The alternative route of drug approval is the abbreviated New Medicinal Product Development (ANMD). It must be approved in steps by the European Medicines Agency (EMEA) before reaching the FDA. The FDA does not approve products that have already been approved by other authorities in the EU, but it does review new products to evaluate safety (including any safety concerns identified by the EMEA). The benefits of the ANMD are that it is faster and easier than a traditional route of drug approval. It also allows companies to obtain greater certainty once they have completed the first steps, especially if significant risks are understood and addressed. The main risks are additional costs and delays in reaching Phase III trials. The alternative route is also used by some companies to obtain medical devices and biologics, where they must adhere to the equivalent EMA process. The FDA's role in the ANMD process is far more involved than with a traditional route of drug approval. The agency provides