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The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health. Read More
Draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments on the draft. Read More
Patients will play a bigger role in device assessments, and more data will come directly from patients in the future, FDA Commissioner Robert Califf told devicemakers. Read More
Although industry overall commended the FDA for developing guidelines for next-generation sequencing technologies for infectious disease diagnostics, stakeholders questioned whether the agency’s reference-grade databases would be sufficient to detect the vast majority of pathogens in the near future. Read More