FDA guidance development will "in general" provide for public input, Schultz says.
This article was originally published in The Gray Sheet
Executive Summary
FDA GUIDANCE DEVELOPMENT POLICY WILL "IN GENERAL" PROVIDE FOR PUBLIC COMMENT, as well as an appeals process for manufacturers objecting to a guidance, FDA Deputy Commissioner for Policy William Schultz said Sept. 14 at a House Government Reform Committee hearing. The policy will be released in October, Schultz told the hearing, which was held jointly by Rep. Christopher Shays' (R-Conn.) Human Resources Subcommittee and Rep. David McIntosh's (R-Ind.) National Economic Growth Subcommittee.