News dal mondo
15
Mar
Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing. A USP official discussed both reports, as well as his perspectives on the industry’s adoption of advanced manufacturing methods, in an interview with Focus...[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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EDQM - Requirements for the content of the CEP dossier according to the CEP 2.0 and updated application forms
11 Mag
US FDA - Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
FDA Issues Discussion Paper on Artificial Intelligence and Machine Learning in Drug Development
08 Mag
Covid-19, Ministero Salute: “Da oggi possiamo dire che l’emergenza sanitaria Covid-19 è alle nostre spalle”
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