Judge foils FDA plan to regulate lab-developed tests
The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...
Just Food on MSN9d
FDA pushes back deadline for food traceability rule
Originally set for 20 January 2026, the Food Traceability Rule aims to boost traceability and reduce foodborne illness.
Food Processing12d
FDA Extends Compliance Date for Food Traceability Rule
FSMA Sec. 204(d) was to take effect Jan. 1, 2026. Even though it was finalized three years ago, the food industry indicated ...
MEAT+POULTRY6d
FDA to extend FSMA compliance date
The original compliance date was to be Jan. 15, 2026. In its Constituent Update March 20, the FDA confirmed that the ...
The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.
The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
JD Supra5h
Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are ...
ConsumerAffairs11d
FDA food traceability rule delayed after lobbying
The FDA delayed the food traceability rule by 30 months, giving food businesses more time to meet requirements they argue are ...
National Law Review2d
In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests
In the never-ending saga over the battle to regulate laboratory-developed tests (LDTs), the Eastern District of Texas took ...
JD Supra9d
FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP ...
Food Engineering9d
FDA to Extend Compliance Date for Food Traceability Rule
The agency says entities well positioned to meet the original January 2026 compliance deadline have expressed concern about ...
The National Law Review10d
FDA Plans to Extend Compliance Date for Food Traceability Rule
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