In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
9/6/2023
/ Clinical Trials ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Scientific Research
As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s...more
A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection...more
When analyzing the life cycle of any health care product, a key component to consider is how much the product will cost and who will pay for it. What unique challenges do direct access tests (DATs) pose when it comes to...more
What are the various factors impacting stakeholders in the direct access testing industry?
By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the...more
The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the...more