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After the EMA issued a report on its adaptive pathway, a German agency took the agency to task for leaving stakeholders in the dark on real-world evidence use. Read More
Drug sponsors that have falsified data will face three years of probation before being allowed to refile marketing applications, the Chinese FDA says. Read More
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More
Juno Therapeutics has been sued in a class-action lawsuit alleging that the company violated federal securities law by failing to disclose a death during a clinical trial. Read More
Plasma fibrinogen can be used as a biomarker in interventional clinical trials examining patients at high risk for exacerbations or all-cause mortality in chronic obstructive pulmonary disease, according to final guidance to industry issued by FDA. Read More
A German agency criticized a report on the EMA’s adaptive pathway, taking the agency to task for leaving stakeholders in the dark on use of real-world evidence. Read More
The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements. Read More