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When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Actavis plans to buy Forest Labs in a $25 billion deal that would expand the company’s reach into the primary care market and add to its pipeline in a wide range of diseases. Read More
New data collection methods show more trials than previously thought need to meet their postmarketing requirements (PMR) and postmarketing commitments (PMC), a new FDA report says. Read More
In another blow to Aveo’s oncology pipeline, Astellas announced it is ending a global partnership with the company to develop its troubled cancer drug tivozanib by August 11. 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 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
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