PDP policy requirement for design verification data to be modified by FDA.
This article was originally published in The Gray Sheet
SIMPLIFIED PDP OUTLINE UNDER CONSIDERATION BY FDA as a complement to its comprehensive policy on product development protocols. The agency says it would like to retain the existing policy because it would be helpful to manufacturers less familiar with the premarket review process, such as new start-ups. However, it also wants to address complaints from some manufacturers that the comprehensive policy is too detailed and prescriptive, and to this end may develop a simplified format.
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