MedTech Dive5h
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 ...
360Dx1h
Future of LDT Oversight Unclear Following Court's Rejection of FDA Rule
The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.
Just Food on MSN8d
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 Processing11d
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 ...
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 ...
National Law Review1d
FDA Announces “Operation Stork Speed”
FDA announced that, at the direction of Health and Human Services Secretary Robert F. Kennedy Jr., it is “taking steps to ...
National Law Review1d
FDA’s New Transparency Tool Addresses Chemical Contaminants
Recently, the Food and Drug Administration (FDA) introduced a new online resource called the Chemical Contaminants ...
JD Supra8d
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 ...
Zacks Investment Research on MSN5d
DXCM Stock Falls as FDA Warnings Raise Concern for 15-Day G7 Approval
DexCom DXCM is facing regulatory scrutiny following a warning letter recently posted by the FDA. This could affect the ...
ConsumerAffairs10d
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 ...
JD Supra6d
Why Compliance Audits Are Non-Negotiable
In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and ...
WuXi AppTec's Changzhou and Taixing API Sites Successfully Pass FDA Inspections
WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the ...