
Which Recent FDA Webinars Are Most Useful for the LDT Rule?
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines