December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...

Data Integrity is currently a MAJOR focus area during regulatory inspections. It is therefore essential that your team have the correct understanding of what is required. This online data integrity ...

The oncology injectable manufacturing of Zydus in SEZ1, Ahmedabad, has received two observations from the U.S. Food and Drug Administration (U.S. FDA). The pre-approval inspection at the oncology ...

Government regulations may make the cost of housing unacceptably expensive, but the majority of Americans are not living below the poverty line.

President Biden delivered one of the many eulogies for Carter. President Joe Biden, President-elect Donald Trump, former presidents and other dignitaries came together Thursday to honor the life of ...

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform FDA clearance marks a pivotal milestone in ViTAA’s broader AiORTA™ suite, ...

PRAME Cell Therapy: Global, randomized, controlled Phase 3 trial, SUPRAME, in previously treated advanced melanoma ongoing; interim and final analyses will occur in 2026Anzu-cel (IMA203) PRAME Cell ...

Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling ...

West Orange lawmakers also file bills to expand public records exemptions, regulate xylazine and e-bikes and mandate mediation for property insurance claims.

“I was isolated, humiliated and broken.” A male teacher tells how his career and marriage were destroyed by false allegations – and a system that denied him justice. He has spoken out, on condition of ...