News dal mondo
20
Feb
Generic industry against giving fee breaks to firms setting up operations in the US
The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs) in the US during user fee negotiations. The issue of fee waivers was one of the topics discussed under the Generic Drug User Fee Amendments (GDUFA IV) for fiscal years 2028 to 2032. The industry and FDA held a series of meetings on 14 and 21 January to address pressing concerns relevant to the industry...[RAPS]
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US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics.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
19 Mar
Nuove norme UE sui farmaci: più incentivi all’innovazione e controllo della disponibilità
As Iran war squeezes Middle East drug shipments, experts warn of longer-term effects on US manufacturing, generics
Farmalabor: investiti 8,5 milioni in un progetto per le malattie rare
17 Mar
EMA Management Board: highlights of March 2026 meeting
13 Mar
Dal China all’India-shoring, il rischio di una nuova dipendenza
11 Mar
EU Finalizes Pharma Reform Package, Clarifies New Rules On Modular Market Protection
PFAS restriction proposal: ECHA’s Socio-Economic Analysis Committee agrees its draft opinion
Farmaci - Gemmato: In cantiere anche un ritorno nazionale alla chimica farmaceutica di base
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