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]
23
Apr
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...
US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...
le ultime news
27 Gen
Tariff Uncertainty Drives Short-Term Manufacturing Surge as Global Pharmaceuticals Enter Fragmented Growth Phase
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