Comments Sought on Requirements for Investigational Animal Drugs
11/10/2004
Federal Register Notice: FDA is seeking public comment on the reporting and recordkeeping requirements for “New Animal Drugs for Investigational Use.” A sponsor must submit to the agency a Notice of Claimed Investigational Exemption (INAD), before shipping the new animal drug for clinical tests in animals. The INAD must include (1) identity of the new animal drug, (2) labeling, (3) statement of any nonclinical laboratory studies’ compliance with good laboratory practices, (4) name and address of each clinical investigator, (5) the approximate number of animals to be treated or amount of new animal drug(s) to be shipped, and (6) information regarding the use of edible tissues from investigational animals. Comments should be submitted by 1/10/05. To view this notice, click here.
