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The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care [Video]

Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more

Full Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown

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

Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care [Video]

Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing. We've covered reimbursement...more

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

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 This update follows FDA’s draft guidance, which was issued in July...more

FDA’s LDT Proposed Rule Heads to the White House

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

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more

The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. During that time, FDA has also asserted that it...more

FDA Issues Update to Guidance for Clinical Trials During the COVID-19 Pandemic

On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten...more

FDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic

On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”)....more

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