The comment period on FDA’s draft guidance on cGMPs for combination products has been extended until April 23. The draft was issued in January (IPQ “News in Brief” January 27, 2015). The Regulatory Affairs Professional Society (RAPS) in conjunction with FDA held a workshop to discuss the new draft guidance and collect industry feedback on April 1. The applicability to legacy products and reserve samples/stability testing were among the issues of concern.
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