Company Questions Remain Unanswered In FDA's Combo Products GMP Rule
This article was originally published in The Gray Sheet
Executive Summary
FDA's proposed "streamlined approach" to combination product manufacturing raises a number of practical questions such as what elements are actual components of a combo product and at what stage the streamlined system kicks in, firms say
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FDA says final rules on good manufacturing practices and adverse event reporting for combination products could be out as early as this fall.