Issue Date: July 20, 1998
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
Women and Minorities Guidance Requirements
The process of implementing this section of FDAMA was logically divided into two stages. During the first stage, existing guidance was identified and evaluated to assess whether it was adequate, whether additional guidance was needed or whether there was insufficient information at this time to make such a determination. The outcome of this first stage would dictate whether another stage, which might include gathering additional data and drafting additional guidance, would be needed.
Download the Guidance Document
