New Drug Review System and Postmarket Safety Issues in the U.S.
According to a recent study published in the Journal of the American Medical Association (JAMA), about a third of the drugs the Food and Drug Administration (FDA) approved between 2001 and 2010 were involved in some kind of safety event after reaching the market. Since 1990s, FDA has been managing to accelerate the speed of new drug review, but many experts worry that the frequency of postmarket safety problems would increase with faster approval. The balance between review speed and drug safety has always been a difficult subject. We should all keep in mind that it is crucial for continuous monitoring of the safety of drugs throughout their life cycle.