Have you ever wondered who controls the tests your can take when you’ve been diagnosed with cancer? Doesn’t seem like a big deal if it’s something your doctors say you need right? I’m sure most of us have never thought about it. If you need a certain test you should be able to take it right? Maybe. Maybe not. Read below and learn more about FDA regulations regarding cancer patients (not just lung cancer patients). Join us Thursday, 1/15 at 7 pm central for an informational, educational chat. I promise you will learn something useful!
The US Food and Drug Administration (FDA) announced its intention to regulate laboratory developed tests. Under the FDA’s proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) — which treats LDTs as medical devices and healthcare providers as manufacturers — laboratories would have to submit applications for expensive premarket review for thousands of LDTs if they wish to continue offering them to patients. This could limit access to life-saving genomic testing for patients who have cancer and other conditions treatable with targeted drugs.
This Thursday, January 15, 2015, at 8 PM Eastern, the subject for #LCSM Chat will be “Should the FDA regulate which cancer tests you can have?” We invite patients, caregivers, doctors, researchers, professional societies, advocates, and regulators in all cancer communities to participate in this discussion. Your moderator will be Janet Freeman-Daily.
Our discussion topics:
- T1: What info about an LDT would give you confidence…
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