Significantly neither FDA, industry groups, nor any other entity has an educated guess on how prevalent the use of RUO and IUO products is within laboratory developed tests (LDTs).

WASHINGTON, DC, August 30, 2011—The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, "Commercially ...

While FDA has long made it clear that companies could not promote RUO and IUO products for diagnostic uses, the agency had never laid out specific parameters. The draft guidance document helps ...

FDA announcement of plans to conduct quantitative research studies to explore consumer responses to draft Front of Pack FOP symbols that manufacturers could voluntar ...

"The selected nutrients and the nutrient levels required for eligibility vary among the different symbol programs in use. With the increasingly widespread availability of these symbols from ...

Although the standalone rule is optional for drug companies, the FDA estimates the resulting reduced workload will produce annual savings of up to $25.5 million. More article on medical devices: ...

WASHINGTON – Next month, General Mills Inc. and Kellogg Co. will begin emblazoning their breakfast cereals with symbols that summarize complex nutritional information – part of the grow… ...