Zdrowie i gospodarka · 06/10/2015

FDA Reopens Comment Period for Draft Guidance on CMC Changes for Approved Drug and Biologic Products

The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance on reportable chemistry, manufacturing, and controls changes for approved drug and biologic products, originally published in the Federal Register on June 1, 2015. Interested persons now have additional time to submit comments.