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Guidance on PET sounds starting siren on 3-year NDA race

By Gareth Macdonald , 04-Dec-2012

Positron emission tomography (PET) drug manufacturers have three years to gain NDA or ANDA approval or they must remove their products from the market according to the US FDA.

The December 2015 deadline was set in new guidelines  issued this week to help producers of PET drugs – which are used in cancer and neurological disease screening – bring manufacturing processes up to code.

PET drugs have always been subject to the same quality requirements as therapeutic drugs. However, historically the FDA did not deem them a priority and granted the academic institutions that produced them for research purposes a degree of manufacturing leeway.

In recent decades clinical use of these agents has increased – including in clinical trials - meaning that their production has become more commercialised, which prompted the FDA to pay closer attention to the way in which they are manufactured.

In 2009, the agency issued its current good manufacturing practices (cGMP) for PET drugs – some four years after it issued draft requirements  – introducing the requirement that they be produced in accordance with cGMP standards by December 2011, although this deadline was later pushed back to June this year.

This new guidelines issued this week take the regulation process a step further and require that PET drug manufacturers hold an approved new drug application (NDA), an abbreviated NDA application or an effective IND by the end of 2015.

The agency said that: “If the PET drug used in the clinical trial is being made at a facility for which manufacturing data have been submitted in an NDA or ANDA for the PET drug, then FDA does not intend to object to use of the PET drug in a clinical trial without an IND until December 12, 2015.

However, if significant manufacturing deficiencies are found during the NDA or ANDA review, or during inspection of the facility the PET drug is sourced from, FDA may notify the sponsor that the PET drug may no longer be used in clinical trials.”

Wave auf wiedersehen to PET submission difficulties

For some PET drug manufacturers unfamiliar with the approval process the prospect bringing existing production methods up to code may be daunting, which the FDA acknowledged in the new guidance.

FDA recognizes that it may be very difficult to develop NDAs for certain PET drugs that are currently in clinical use.  This guidance specifies that expanded access is available for these types of drugs.”

The agency then sets out how manufacturers should submit applications and what safety information they will need to provide. The guidance builds on the media fill information the agency provided earlier this year.   

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