US FDA Commissioner Scott Gottlieb told a Medical Device Manufacturers Association crowd that he will try to assure more balance between device and drug regulatory leads for combination product reviews at the agency.
US FDA is working hard to create a more efficient consultation process between different regulatory centers, but also one that is fair for all sponsors of combination products, whether for combination device and drug, device and biologic, or drug and biologic products, Scott Gottlieb said May 3.
But device manufacturers continue to perceive that it is the drug center at FDA, rather than the device center, that typically calls the shots on drug-device combination product reviews, Medical...
A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
