Elemental Impurities in Animal Drug Products-Questions and Answers; Draft Guidance for Industry; Availability; Reopening of the Comment Period

الملخص

The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice of availability that published in the Federal Register on March 27, 2018. In that document, FDA requested comments on the draft guidance for industry (GFI) #255 entitled "Elemental Impurities in Animal Drug Products--Questions and Answers." The Agency is taking this action in response to requests for an extension to allow interested parties additional time to develop and submit comments.