“The Tome” to be broken down

Executive Summary

FDA's proposed rule on safety reporting requirements (dubbed "The Tome" for its large size) could be divided into "discrete pieces" to make it more palatable when it is finalized, Office of Pharmacoepidemiology & Statistical Science Director Paul Seligman tells Drug Information Association annual meeting. CDER Acting Director Steven Galson says the proposed rule, released in March 2003, is undergoing some "very, very serious surgical work" and the final reg will probably be something "quite different"...