Simplifying Global Compliance
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
Chinese authorities are urging vaccine manufacturers to implement better adverse event reporting procedures during clinical research and to adhere to reporting timelines. 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
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
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
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
In a 9-0 decision, the U.S. Supreme Court ruled Jan. 22 that the patent holder bears the burden of proof for infringement, regardless of whether it is the plaintiff or defendant in a patent lawsuit. Read More
Drugmakers have 60 days to resolve safety concerns about products once they have been flagged by an EU member state. 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
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
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
Drugmakers should clearly define their validation activities in a validation master plan that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More
The Pharmaceuticals and Medical Devices Agency is asking drugmakers to submit information on stability monitoring and water purity when they apply for mandatory postapproval good manufacturing practice inspections. Read More
EU drug approvals jumped 42 percent in 2013 over the previous year as the European Medicines Agency authorized 81 new drugs for marketing. Read More
A U.S. Food and Drug Administration review of drug approvals and denials over a 12-year period shows many delays could be avoided if drugmakers submitted more accurate and useful information. Read More
Drugmakers should be careful not to use language in product labeling that could be considered promotional, such as comparisons with an alternate treatment, a Health Canada final guidance says. Read More
The European Medicines Agency is following in step with U.S. regulators and, at the request of Sweden’s medicines authority, is reviewing the efficacy of emergency contraceptives in heavier women. Read More
The U.S. Department of Justice wants to rid the pharmaceutical industry of pay-for-performance sales compensation packages, believing they fuel fraud, off-label marketing and other deceptive behaviors, a former top prosecutor says. Read More
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