FDA MAY REQUIRE LONGER STUDIES BEFORE CLEARING PSYCHIATRIC DRUGS
October 21, 2005 07:13

Federal regulators are considering requiring drugmakers to perform longer-term studies of many psychiatric medications before they can be approved for marketing in the U.S. In documents posted on its website, the Food and Drug Administration said for the past six months, it has been asking manufacturers to provide "longer- term efficacy data" for psychiatric drugs that treat chronic conditions. But the shift has met with resistance from companies and some researchers, who have said it will slow the process of developing new drugs, said Thomas Laughren, acting director of the agency's division of psychiatry products.

Leila Abboud And Anna Wilde Mathews, The Wall Street Journal, 10/18/2005.