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Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Sep 22nd, 2015

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Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

Also drawing industry attention at the meeting were the statutory authority for the reporting expectations delineated in the draft guidance and how they apply to active pharmaceutical ingredient (API) suppliers and contractors.

The draft guidance and a substantive Federal Register notice accompanying it were released by FDA in late July (IPQ Aug. 23, 2015).

In line with industry requests voiced at the meeting for more time to digest the draft guidance and to consider the specific questions on which the agency had asked for more input (ibid.), a follow-up Federal Register notice was issued on August 27 providing for a 60-day extension on the written comment period to November 27, 2015. [A link to the notice is provided below.]

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