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Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More
The FDA has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More
The European Medicines Agency is seeking feedback on draft guidelines on conditional approval and accelerated assessment as it strives to fast track medicines for unmet medical needs. Read More
The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills. Read More
Drugmakers making changes to analytical validation methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
Drug compounding groups are urging the FDA to revise a draft memorandum of understanding that outlines how states should regulate small compounders, saying a proposed cap on interstate shipments of compounded products would hinder patient access and unduly burden state enforcement agencies. Read More
The European Medicines Agency is declaring that six classes of diseases occur in children, forcing drugmakers to conduct pediatric tests prior to approval. Read More