Drug pipeline activity is monitored very closely from the time the drug or compound is identified in the laboratory until it is successfully marketed to the consumer. Government regulations outline intense testing to determine the efficacy and safety of the proposed drug compound. A loose estimate suggests that for every marketable pharmaceutical there are as many as 5,000 possibilities that do not make it through the process.

Drug pipeline directories are also called "drugs in development." This is a summary of every entry stating the progress of the process as the data is compiled. This includes regulatory, scientific, commercial, and patent information. During any phase of the process, a compound may be determined toxic or ineffective. At this time, it is pulled from the study for further evaluation.

Drug Pipeline Forms for the FDA

Two documents must be filed with the FDA by companies desiring drug approval. The first is after pre-clinical animal testing. This must prove successful with no adverse results over a period of years. At this time, application may be made to recognize the drug as an investigational new drug for testing on humans. There are three or four clinical trials required to substantiate the safety and effectiveness on humans.

The next step in the drug pipeline is to make application for the FDA to approve the drug for marketing. The entire process can take as long as 12 to 15 years from time of discovery until it is marketed. There are requirements by the FDA for the manufacturer to keep the FDA informed of the safety and effectiveness of the drug. Some new drugs require further testing and formulation after long-term use.