FDA Seeks More Data On Radiopharmaceuticals

The agency is seeking White House approval for the collection of data from manufacturers.
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A U.S. government agency is seeking White House approval for the collection of data from the manufacturers of diagnostic radiopharmaceuticals that supports the safety and effectiveness claims of those companies’ products.

On Oct. 5, the Food and Drug Administration (FDA) posted a Federal Register notice—Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for InVivo Radiopharmaceuticals Used for Diagnosis and Monitoring—seeking comments on the proposed collection of data. In addition, the FDA said the proposed collection of information has been submitted to the White House Office of Management and Budget (OMB) for review and clearance.

When administered to a patient, radiopharmaceuticals enable medial diagnostic equipment to image the extent of a disease-process in the body based on the cellular function and physiology, rather than relying on physical changes in the tissue anatomy. In some diseases nuclear medicine studies can identify medical problems at an earlier stage than other diagnostic tests.

The Federal Register notice says the FDA is requesting OMB approval of the proposed increased in data collection requirements placed on the manufacturers of diagnostic radiopharmaceuticals.Those manufactures are currently required to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical or of a new indication for use of an approved diagnostic radiopharmaceutical.

The FDA amended its diagnostic radiopharmaceuticals regulation on May 17, 1999 by adding provisions that clarify the agency’s evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases. The regulation describes the kinds of indications of diagnostic radiopharmaceuticals and some of the criteria the FDA uses to evaluate the safety and effectiveness of a diagnostic radiopharmaceutical, the latest notice says.

The proposed regulation “clarifies existing FDA requirements for approval and evaluation of drug and biological products already in place,” the notice says. “The information, which is usually submitted as part of a new drug application or biologics license application or as a supplement to an approved application, typically includes, but is not limited to non-clinical and clinical data on the pharmacology, toxicology, adverse events, radiation safety assessments, and chemistry, manufacturing, and controls,” the notice says.

The deadline for comments is Nov. 4, 2011.

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