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An updated Health Canada guidance on quality information drugmakers must submit with marketing applications includes harmonized references on how to document a quality-by-design approach during drug development. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has released a guide for drugmakers on how to differentiate between defects, errors and adverse drug reactions and what to do when quality defects are suspected. Read More
The European Medicines Agency is asking drug companies to keep pharmacogenomics in mind when doing pre- and postauthorization safety assessments, noting that the selection of biomarkers is key to maintaining a robust safety profile as part of pharmacovigilance activities. Read More
Brand drugmakers last month denied accusations they’d joined forces with a lobbying group in a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More
The European Medicines Agency says it’s no longer acceptable for sponsors to conduct placebo-controlled clinical trials when developing monotherapy drugs for lipid disorders. Read More
The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to first seek the agency’s blessing and get qualification or prospective advice. Read More
Japanese officials launched an investigation Jan. 10 into claims that falsified clinical trial data were used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse. Read More
Chinese authorities are urging vaccine manufacturers to implement better adverse event reporting procedures during clinical research and to adhere to reporting timelines. Read More
Videotapes of patients giving informed consent to participate in clinical trials must show the investigator explaining the study protocol in language the subject can understand, according to a draft guideline by India’s Central Drugs Standard Control Organization. Read More
FDA advisors want stronger warning language on labels for non-steroidal anti-inflammatory drugs, or NSAIDs, saying language added in 2005 is not strong enough and may lead doctors and patients to think there is no risk of cardiovascular (CV) blood clots in short term use of the drugs. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More