Draft guidance from the US Food and Drug Administration for implementing new statutory reporting requirements on pharmaceutical manufacturing activity drew a sharp response from industry by the 3 January comment closing date. Commenters were primarily concerned over the deadline the agency set, just weeks away, for filing initial reports.
The document, “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Food Drug & Cosmetic Act,” was released on 29 October and spells out how to implement the facility- and product-specific manufacturing reporting requirements outlined in the 27 March 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act
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