News dal mondo
20
Feb
US FDA: svolta storica: basterà un solo studio registrativo per approvare i nuovi farmaci
La Food and Drug Administration cambia paradigma: per l’approvazione dei nuovi farmaci sarà sufficiente un unico studio adeguato e ben controllato, superando la storica prassi dei due trial registrativi...[PharmaStar]
30
Apr
AIFA pubblica il Terzo Position Paper sui farmaci biosimilari
È online il terzo Position Paper AIFA sui farmaci biosimilari. L’aggiornamento del documento...
29
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...
28
Sun Pharma compra Organon
Sun Pharmaceutical Industries ha firmato un accordo definitivo per acquisire Organon &...
27
US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity...
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
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