News dal mondo

29

Apr

US GDUFA IV Talks Reach Tentative Agreement; America First Application Fee Waiver Added

US FDA GDUFA Reauthorization performance goals and program enhancements Riscal years 2023-2027 - Meeting 23 giugno 2026

[Federal Register Volume 91, Issue 72 - April 15, 2026]

18

Giu

AIFA Sistema informatico Workflow Officine Materie Prime - Ulteriore Aggiornamento tecnico 18 maggio 2026

Formati files ammessi: PDF editabile o p7m. Scansioni a 200 dpi, anche in bianco e nero, per ottimizzare...

15

Mag

US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry

We have written on this blog about FDA’s modernization agenda from several angles lately—from...

15

Mag

EU Regulators discuss new pharma legislation, AI, and more

A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence...

15

Mag

US FDA official details top observations from QMSR inspections

The top observations identified in Form 483 reports from inspections conducted under the recently implemented...