FDA issues guidance clarifying good lab practice regulations

09/3/2013 | Clinica (subscription required)

Draft guidance clarifying good laboratory practice rules governing nonclinical trials related to medical devices has been released by the FDA. The guidance, which is up for comment through Nov. 26, explains issues such as the types of medtech marketing applications or studies covered by the GLP rules and the types of GLP data that should be furnished to the FDA.

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