A Diagnostics & Imaging Week

Pursuant to an agreement FDA hammered out with makers of radiological diagnostics, FDA has published a draft guidance to address the mix-n-match nature of scanning machines and contrast agents that are already on the market. While the draft promises a dose of much-needed clarity, the document also suggests that for at least some new combinations, a PMA will be required.

The draft guidance makes explicit that it addresses only "new contrast indications using an already marketed imaging drug, and the guidance aims to deal with three issues. One is the ability to add contrast agents to the list of allowed agents for a given imaging device "without having modification of labeling for both the device and the drug."

FDA also wants to standardize the scientific and technical information it takes in from industry in pursuit of new combinations "regardless of the type of submission" used for the contrast agent and the imaging equipment, but FDA also acknowledged that the format of the data submitted is also a consideration in hammering out the guidance.

Getting a new combination through FDA might require an application per the device if the new use is consistent with the contrast agent's current approved indications and involves no changes to route of administration, formulation and dose, according to the guidance. In this scenario, the sponsor would be able to add the contrast agent to the list of agents approved for that device without "the need for a conforming change to the imaging drug labeling."

Conversely, if a sponsor wants to make changes to the formulation, dosing, or route of administration for a drug in conjunction with an imaging device that already has a PMA or a 510(k), the holder of the drug or biologics approval will have to submit at least a supplement to FDA. In the case of a tweak to the agent that allows "enhanced biodistribution to a new area but using the same imaging software," the agency may want to see a new drug application.

Any change to the previously mentioned characteristics of the contrast agent that would force a change in the performance characteristics of the imaging equipment – or vice versa – would likely require a submission of some sort for both components, the guidance states. FDA also indicated that a 510(k) may do the job "if the approved imaging drug and cleared imaging device are already indicated for the same or consistent contrast indication."

In virtually any case, the effort will be neither cheap nor easy. FDA states in the guidance "the safety and effectiveness of the new contrast indication should be established by data collected from appropriately designed clinical trials using both the drug and the device." FDA also indicated that post-market surveillance may be necessary beyond adverse event reporting, but offered no detail.

LabCorp warned for homebrew Dx

A Sept. 29 FDA warning letter to Laboratory Corporation of America (LabCorp; Burlington, North Carolina), dealt specifically with the firm's web site, which FDA stated contained information about the OvaSure diagnostic. The warning letter indicated that the diagnostic "is a test that was designed, developed, and validated by investigators at Yale University (New Haven, Connecticut) and not by LabCorp." The warning letter went on to essentially state that the diagnostic was still under home-brew rules and as a consequence, LabCorp's description of the OvaSure at its web site violates regulations.

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