FDA has finalized a guidance on positron emission tomography (PET) drug media fills that was released as a draft last September and has effectively extended the December 2011 deadline for PET drug application submissions until June.
The guidance is intended to help manufacturers of PET drugs meet the requirements for the agency’s CGMP regulations for PET drugs (21 CFR 212). Most are designed for parenteral administration and are produced by aseptic processing. Performance of a media fill is required to test whether the aseptic procedures used are adequate to prevent contamination during actual drug production.
The agency notes in the “background” section of the final guidance that it will exercise “enforcement discretion” to allow PET drug manufacturers more time to complete the applications, and will not take action against a PET facility for failure to meet the deadline so long as the facility complies with all other FDA requirements.
If a facility “wishes to continue to produce PET drugs for clinical use after the June 12 deadline,” the agency explains, the firm must have submitted an approved new or abbreviated new drug application (NDA or ANDA) or be operating under an investigational new drug application (IND) prior to that date.
FDA emphasizes that PET drug producers unable to submit an application by the deadline “must find a new supplier who has submitted an NDA or ANDA” and that all PET producers must be operating under an approved NDA, ANDA or effective IND by December 12, 2015.