Criteria That FDA Uses In Deciding To Approve A New Drug

There are different phases of developing a new drug. The first phase is a preclinical phase. The duration of this phase lasts for up to 3 to 4 years before applying for FDA. Through every phase, right from creation of the drug to getting the FDA approval, clinical trials are performed at every stage. Once the application for the FDA is approved, the next phase lasts for another 3 to 4 years before the drug gets into the market. The manufacturer of the drugs can then file an application for the new drug along with the FDA approval.

CDER is the largest of FDA’s six centers.   It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs. For more information on CDER activities, including performance of drug reviews,  post-marketing risk assessment, and other highlights, The other five FDA centers have responsibility for medical and radiological devices, food and cosmetics, biologics, veterinary drugs, and tobacco products. Source: www.fda.gov

There are thousands of drugs that enter the list of FDA for approval. Only one or two drugs receive approval amongst these. It takes millions of dollars to develop a new drug. For a new drug to pass the FDA test requires laboratory and animal testing. A company that comes up with a new drug has to submit an Investigation New Drug application so that it goes to the FDA for a review. FDA monitors that every clinical test done on these drugs is safe for human use.

There has to be more benefits than risks involved in the drug testing, so that it can get to the market for sales. If the drugs show side effects or unexpected outcomes in different circumstances, this is mentioned in the drug labels. The clinical trials and its effects are analyzed by a team of experts.

There is still no standard integrated health care system. Rare side effects cannot be known always. The health insurance data bases receive the latest updates of any new drug in the market. Effects of all the compounds in the drug are meticulously analyzed for any potential harm to the human.