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]
08
Mag
Farmaceutica, Gemmato: 'per Testo unico deadline entro dicembre'
"Il Testo unico sulla legislazione farmaceutica, che ha come obiettivo quello compendiare 800 fra...
Min. Salute Gemmato: “Testo unico farmaceutico entro dicembre 2026”
Il sottosegretario alla Salute indica la tabella di marcia della riforma. Al centro accesso ai farmaci...
Precursori droghe: controllo esteso a 9 nuove sostanze dal 18 settembre 2026
Regolamento delegato (UE) 2026/314 della Commissione del 9 febbraio 2026 recante modifica del regolamento...
US FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
The U.S. Food and Drug Administration (FDA) on Wednesday unveiled a one-day inspectional assessment...
le ultime news
20 Mar
Iran, blocco Hormuz su produzione farmaci: 'se dura ci sarà impatto tra 6 mesi'
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
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