News from the world
16
Feb
FDA’s Inspections of Foreign Drug Mfg Facilities
The FDA’s inspection process for foreign drug-manufacturing facilities came under scrutiny once again with Congress holding a hearing questioning the frequency and quality of FDA’s foreign drug inspections. What may be next?...[DCAT]
24
Apr
EMA Unveils Recommendations to Tackle Critical Medicine Shortages
Identifying and reducing production and delivery vulnerabilities are the focus of the European Medicines...
22
EMA Launches Medicine Shortages Monitoring Platform
To detect, prevent and manage medicine shortages in the EU and European Economic Area (EEA), the European...
WHO issues guidance on nitrosamine controls in drug manufacturing
The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing...
FDA aims for greater use of remote assessments for low-risk facilities
The US Food and Drug Administration (FDA) has conducted more than 20 remote regulatory assessments (RRAs)...
latest news
04 Apr
Europe’s generic medicines are disappearing, study finds
US FDA - The Office of Pharmaceutical Quality (OPQ) Issues Annual Report for 2023
02 Apr
AIFA - Aggiornamento Tariffe ISTAT dal 1 aprile 2024
21 Mar
EU pharmaceutical policy: MEPs support comprehensive reform
20 Mar
Riforma farmaceutica: il Parlamento Ue non tocca (quasi) i tempi della tutela regolatoria
15 Mar
US FDA Final Guidance: Controlled Correspondence Related to Generic Drug Development
FDA publishes artificial intelligence paper
14 Mar
Intelligenza artificiale: il Parlamento europeo ha approvato l’Ai Act
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