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]
27
Apr
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...
23
Top Drugs at Risk of Supply Shortages
Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...
Regulatory considerations for pharmaceutical excipient selection
The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...
21
TGA clarifies therapeutic goods are unaffected by chemical production and import ban
TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...
le ultime news
27 Apr
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20 Apr
US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
Alfasigma cede a Fine Foods il 100% di Sofar
17 Apr
Sostanze stupefacenti, il Ministero aggiorna le tabelle: inclusa la classe dei Nitazeni tra le sostanze vietate
Gemmato: 'Iran. Rschio carenze farmaci, legge delega per rafforzare produzione nazionale. Convocherò tavolo'
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