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The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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 FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.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FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]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...
le ultime news
04 Mar
ECHA’s Risk Assessment Committee adopts its opinion on PFAS restriction proposal
27 Feb
US FDA Announces the 2026 QMM Prototype Assessment Protocol Evaluation Program
Quantum computing nelle life sciences: a Milano un convegno per l’industria farmaceutica
24 Feb
Industry clamors for clearer guidance on transition to ICH M4Q(R2)
23 Feb
USA . La Corte Suprema boccia i dazi globali di Trump: cosa cambia e perché il pharma resta nel mirino
20 Feb
NerPharma acquistata da un colosso farmaceutico francese
Generic industry against giving fee breaks to firms setting up operations in the US
US FDA: svolta storica: basterà un solo studio registrativo per approvare i nuovi farmaci
<<<1 2 3>>>
