Regulatory Guidance

German regulatory agency opens review of Thermo Fisher, Olink deal

By LabPulse.com staff writers

Germany’s antitrust regulatory agency, the Bundeskartellamt, has moved into a phase II review of Thermo Fisher’s acquisition of Swedish proteomics firm Olink.

February 22, 2024

Precision medicine at tipping point with looming FDA LDT oversight

By Liz Carey

FDA targets companion diagnostics (CDx) LDTs first. In addition, CAP and AdvaMedDx set clear expectations, and what to know about the FDA-CMS joint statement on FDA oversight.

January 25, 2024

FDA issues safety warning for risk of T-cell malignancies with CAR T-cell therapies

By LabPulse.com staff writers

The FDA issued a safety warning that patients who have received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies may be at higher risk of developing new T-cell malignancies, including CAR-positive lymphoma.

November 30, 2023

AMP, other stakeholders urge Congress to pause FDA LDT rule, update CLIA

By LabPulse.com staff writers

The Association for Molecular Pathology (AMP) requested Congress to update the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to the FDA’s proposed rule to increase agency oversight of laboratory-developed tests (LDTs).

November 22, 2023

FDA to discuss phaseout enforcement discretion for LDTs

By Liz Carey

In relation to its proposed medical device rule targeting laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) will hold a webinar Tuesday, October 31, at 1 p.m. EST.

October 26, 2023

NIH to require international collaborators to share all data

By LabPulse.com staff writers

Despite concerns from researchers and organizations, the U.S. National Institutes of Health (NIH) will implement its new mandate requiring foreign partners to share raw data and notebooks at regular set intervals with their primary U.S. grant recipients.

September 22, 2023

MedTech Europe calls for IVDR changes, makes recommendations

By Matt Limb

Trade group MedTech Europe is calling for an overhaul of Europe’s medical technology regulatory frameworks to ensure that innovations reach patients and health systems more quickly.

September 19, 2023

NIH to award up to $300M for next-generation COVID tests

By LabPulse.com staff writers

New programs may award up to $300 million in funds from the American Rescue Plan Act of 2021 to support the accelerated development of tests and provide regulatory guidance during the COVID-19 pandemic and beyond, NIH said.

September 8, 2022

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