Zdrowie i gospodarka · 12.01.2018
Determining Whether To Submit an Abbreviated New Drug Application or 505(b)(2) Application; Draft Guidance for Industry; Availability; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability, published in the Federal Register of October 13, 2017. In that document, FDA requested comments on the draft guidance for industry entitled "Determining Whether to Submit an ANDA or 505(b)(2) Application." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.