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The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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 FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]
13
Dal China all’India-shoring, il rischio di una nuova dipendenza
Una ricerca universitaria, promossa da CPA Italy, sulla supply chain di principi attivi e intermedi mostra...
11
EU Finalizes Pharma Reform Package, Clarifies New Rules On Modular Market Protection
A final version of the draft pharma reform package has been published, clarifying changes that the...
PFAS restriction proposal: ECHA’s Socio-Economic Analysis Committee agrees its draft opinion
The European Chemicals Agency’s Committee for Socio-Economic Analysis (SEAC) has agreed its draft opinion...
Farmaci - Gemmato: In cantiere anche un ritorno nazionale alla chimica farmaceutica di base
Il sottosegretario alla Salute Marcello Gemmato è intervenuto durante la presentazione del Rapporto...
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