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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
Drugmakers developing treatments for diabetic and idiopathic gastroparesis should study those patient populations in separate trials, the FDA says. Read More
The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More