FDA issues guidance development plans. (Regulatory Update).(Brief Article)

FDA's Center for Drug Evaluation and Research (CDER) has issued its annual list of planned guidance documents to be developed in fiscal year 2003. As a refresher on the purpose of guidance documents, recall that regulations often can be quite vague in terms of what is required of the regulated community. FDA occasionally will issue additional advice (guidance) on its expectations regarding appropriate compliance with a particular regulation. The availability of a guidance document is either published in the Federal Register, or is announced on the agency's Web site.

Guidance documents are not regulations. They represent the agency's current thinking about a topic. …