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]

13

Mag

Deal on tackling EU shortages of essential medicines

Prioritise investment in EU manufacturing capacity to increase autonomy “Buy European”...

12

Mag

Chimica: Bruxelles non rivedra' le norme REACH

Bruxelles non rivedra' le norme Reach, troppa incertezza per il settore La Commissione europea ha...

08

Mag

Farmaceutica, Gemmato: 'per Testo unico deadline entro dicembre'

"Il Testo unico sulla legislazione farmaceutica, che ha come obiettivo quello compendiare 800 fra...

08

Mag

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...