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The FDA guidance issued earlier this year on how it will use real-world evidence to make regulatory decisions is generally helpful but relies too heavily on registries and the pre-submission process and needs to be clarified, industry groups said in public comments. Read More
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Draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments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