FDA Finalizes cGMP Guidance for ANDA Facilities
August 29th, 2024 // 2:22 pm @ jmpickett
In July, FDA outlined details on how it will assign a goal date according to a drug facility’s readiness for inspection. These rules include information for generic drug makers on how they can determine when drug plants associated with an application will be ready for an FDA audit in support of an ANDA or abbreviated new drug application.
FDA said its goal is to cut the first assessment cycle for premarket drug applications. It also intends to encourage submitting drug applications that include drug facilities that are ready to be inspected to facilitate an efficient and timely assessment.
FDA finalized guidance that lets drug manufacturers obtain an FDA inspection extension for certain drug facilities that are not entirely compliant with cGMPs. This extension is part of an agreement between FDA and the drug industry under GDUFA III, the Generic Drug User Fee Amendment. It states that the sponsor of an ANDA who states in their FDA form that they have a drug facility that is not ready for an audit will be given 15 months to bring that plant into FDA compliance.
The new rule states that the applicant may amend its ANDA to reset the goal date of 15 months to a priority or standard assessment, once all drug facilities are ready to be inspected by FDA. But the commitment letter also lays out that for a drug application that includes a plant that isn’t ready for inspection 30 days before the 15 month extension expires, FDA says it will reset the inspection goal date for another 15 months.
FDA says that it wants to incentivize companies to submit applications that include plants ready for inspections to encourage an on-time, substantive assessment. However, not every ANDA application is eligible for this deferral. It said that drug plants that did bioequivalence and clinical trials to support a premarket application may not quality for the additional 15 months. Nore will ANDAs that have amendments after a complete response or provisional approval letter was delivered to the sponsor.
