News dal mondo

09

Mar

US FDA drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection. This guidance applies to both domestic and international inspections.

FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]

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...