News dal mondo
10
Mar
Generic drugmakers seek clarity on pre-submission facility correspondence
Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic drug applications. In December, FDA revised its draft guidance on submitting PFCs for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug User Fee Amendments (GDUFA III) program. The process can be used by generic drug sponsors to get a priority review goal date for their submission, but the PFC must be submitted two months before they submit their premarket application..[RAPS]
22
Mag
5 Emerging Trends In Complex Small Molecule Drug Production
Product development of new generic molecules starts early in the life cycle of the originator product...
18
Carenze di farmaci. EMA pubblica 10 raccomandazioni per le aziende
La guida descrive le varie parti interessate nella catena di approvvigionamento dei medicinali, le loro...
Report Egualia: Generici, mercato fermo al palo, si rischia che questi farmaci spariscano
Ancora un anno sospeso tra stagnazione e depressione per il mercato italiano dei generici-equivalenti...
17
Carenze farmaci: una proposta per tornare al “Made in Europe” e ridurre la dipendenza dai fornitori (come Cina e India)
After the European Commission proposed a massive overhaul to the EU’s drug legislation,...
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08 Mag
Covid-19, Ministero Salute: “Da oggi possiamo dire che l’emergenza sanitaria Covid-19 è alle nostre spalle”
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