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Facility and Excipient Information Shortfalls Identified by FDA As Among Key Contributors to ANDA Review Delays; GDUFA II Driving Expanded Guidance

Feb 20th, 2018

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FDA’s Office of Generic Drugs (OGD) is cautioning ANDA sponsors to pay more attention to making sure that current information is provided on all of the facilities involved in the development, manufacturing, control testing and warehousing of APIs and finished dosage forms in both the Form 356h and application module 3.2.S.2.

OGD has been highlighting the frequency of the problem of facilities surfacing during the review that are involved in the manufacturing process but not mentioned in the filed application – and warning sponsors of the consequences on approval timelines that can ensue.

At the Association for Affordable Medicines (AAM) annual Fall Technical Conference in November, OGD Office of Regulatory Operations (ORO) Director Ted Sherwood pointed to a survey OGD did during mid-2017 of a set of recently-reviewed applications, which found that 25% of them had these “hidden” facilities.

He noted that the problem surfaced mostly in the DMF context, and that several of those in question had multiple hidden facilities.

The pre-submission facility correspondence (PFC) has been reviewed and the ANDA submitted, Sherwood explained. “Things are moving along, and then a new facility is identified.” The finding drives a mandatory amendment to update the application and throws off the previous timelines – most consequentially, if it is facility with which FDA doesn’t have experience.

OGD Director Cook Uhl also highlighted the extent of the hidden facility problem and the consequent reassignment of the GDUFA goal date that can ensue in her traditional keynote presentation on the “state of OGD” at the conference. “Probably not a week goes by that somebody isn’t saying to me, ‘oh, we found this new facility,” she said.

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