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The FDA has released final guidance on assessing the risks and benefits of investigational device exemption applications for human clinical studies. Read More
Last year’s 21st Century Cures Act directed federal agencies to pursue an international pediatric clinical trials network, and to engage with foreign regulators alongside attempts to align international guidance. Read More
Clinical research organizations and pharmaceutical companies are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Read More
The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More
Pediatric clinical trials protocols should be designed with input from stakeholders, according to the Clinical Trials Transformation Initiative on antibacterial drugs. Read More
International guidance on pediatric drug development should include provisions for remote electronic consent, and should clarify the information provided to patients prior to their enrollment in clinical trials, according to the Association of Clinical Research Organizations. Read More
FDA inspectors observed several violations at a VistaPharm facility in Largo, Fla., including contaminated water used in manufacturing and batches of drugs that were not tested for impurities. Read More
The FDA granted over 99 percent of requests for expanded access in fiscal 2016, including 100 percent of emergency IND applications and protocols. Read More