FDA Approval Process Builds Safety into Its Design

John Klein brings three decades of pharmaceutical industry experience to his current position as chairman of Cambridge Therapeutics. In addition to his service with Cambridge Therapeutics and other for-profit companies, John Klein guided the United States Food and Drug Administration (FDA) approval process for hundreds of new drugs and supplements as a past chairman of the Worldwide Generics Pharmaceutical Industry Association.

The FDA’s Center for Drug Evaluation and Research (CDER) is the conduit through which new medications must pass before they are approved for sale and use within the US. It typically takes about a decade to approve a new drug but that lengthy process helps to ensure that only the safest and most effective medications reach the market. 

Before a drug can even be considered by the CDER team, its manufacturer is first required to conduct thorough rounds of testing according to established protocols. After the CDER receives the documentation noting the test results from a pharmaceutical company, its own cadre of scientists begins to conduct a complete review.

To file an application to have a drug approved for sale, the pharmaceutical company must demonstrate that the drug treats a specific condition and is safe for use by human beings. The company must provide evidence about the drug derived from clinical trials. Its application must also include safety and potential for abuse, directions for patient dosage, and the label information.