Clinical trials databank guidance revised.(Regulatory Update)(Brief Article)

In the Jan. 27, 2003, Federal Register, FDA announced it is revising the March 2002 guidance, Information Program on Clinical Trials for Serious or Life-threatening Diseases and Conditions. The revision is now available as a draft and FDA is seeking comments through March 29, 2004. Written comments may be sent to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane Room 1061, Rockville, MD 20852. Electronic comments may be sent to www.fda.gov/dockets/ecomments. A copy of the guidance document can be found at www.fda.gov/cder/guidance/index.htm and selecting the Modernization Act link and then scrolling down to the Modernization Act (Draft) link. The Clinical …