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The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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 FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]
20
Apr
US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...
Alfasigma cede a Fine Foods il 100% di Sofar
Alfasigma S.p.A. comunica di aver sottoscritto un accordo per la cessione del 100% del capitale...
17
Sostanze stupefacenti, il Ministero aggiorna le tabelle: inclusa la classe dei Nitazeni tra le sostanze vietate
È stato pubblicato nella Gazzetta Ufficiale il Decreto ministeriale 2 aprile 2026, con il...
Gemmato: 'Iran. Rschio carenze farmaci, legge delega per rafforzare produzione nazionale. Convocherò tavolo'
"Un tema molto attuale riguarda il rischio di carenza di farmaci e principi attivi, anche alla luce...
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