FDA Issues Draft Guidance for Gene Therapy Genome Editing Safety
The recommendations focus on using next-generation sequencing to evaluate off-target editing risks and chromosomal integrity.
Category: Compliance
Compliance
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Compliance
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Lab CEO, Physicians, Marketers Pay $6M to Settle Kickback Allegations
Settlement resolves False Claims Act litigation alleging illegal payments disguised as management service organization distributions.
Compliance
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ADLM Calls on HHS to reinstate CLIAC
The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.
Senator Rand Paul Introduces Resolution to Repeal FDA’s LDT Final Rule
Senator Rand Paul announced a resolution to repeal the FDA’s LDT Final Rule, arguing it oversteps authority and threatens medical innovation.
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FDA Announces Final Rule on LDT Regulation
The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act.
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Clinical Labs Say FDA’s LDT Rule Would Hinder Pediatric Care
ADLM released the results of a survey the organization conducted to determine how the FDA’s proposed LDT rule would impact patient care.Â
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Labs Express Concern about Testing Access if FDA Regulates LDTs
Nearly 85% of respondents to an ARUP Labs survey on the impact of the FDA’s proposed rule to regulate LDTs believe it will hurt their labs.
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Is There a Balancing Point for LDT Regulations?
CLP Editor Chris Wolski examines the need for LDT regulations, and issues an industry-wide call to action.
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CMS and CDC Issue Final Rulemaking Updating CLIA Fees
CMS and the CDC issued Final Rulemaking [CMS-3326-F] to update the CLIA fees and clarify the CLIA fee regulations.
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FDA Takes Shot Across the Bow with LDT Rulemaking
The FDA has issued proposed LDT rulemaking. Laboratories have an opportunity to make comments before it becomes official.
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HHS OIG: Labs with Questionably High Billing for Add-On Tests Warrant Further Scrutiny
Certain labs billed Medicare Part B for questionably high levels of add-on tests alongside COVID-19 tests in 2020.
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AACC Statement on Exclusion of VALID Act from Omnibus Bill
AACC issued a statement supporting the U.S. Congress’ exclusion of the VALID Act from its 2023 Omnibus Bill.
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AMP Commends Congress for Nixing VALID Act
The Association of Medical Pathology (AMP) applauded Congress for not including the VALID Act in the Consolidated Appropriations Act of 2023.
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AACC Urges Cutting VALID Act to Preserve Patient Access to LDTs
The AACC is urging clinical lab professionals to write to their legislators to keep the VALID Act out of a Fiscal Year 2023 budget agreement.
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Stop the VALID Act, AMP Urges
AMP is urging medical organizations to contact their elected officials to remove the VALID Act from a 2023 “omnibus” appropriations bill.
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FDA Updates COVID-19 Test Policy
The FDA has updated its COVID-19 test policy to ensure continued access to tests, transitioning traditional premarket review pathways.
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CMS Proposes Rule to Update CLIA Fees & Regulations
The Centers for Medicare & Medicaid Services issued a proposed rule that would update the CLIA 1988 fee regulations.
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Theranos Whistleblowers to Give Fireside Chat at AACC 2022
Erika Cheung and Tyler Shultz—two of the key Theranos whistleblowers—will speak in a special fireside chat at AACC 2022.
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