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Category: Clinical Trial

Clinical TrialFlash News

Health Canada Wants Faster Clinical Trial Registration and Results Disclosure. Is Your Process Ready?

Health Canada now expects covered clinical trials to be registered within 21 days of first participant enrollment and summary results to be disclosed within 12 months of primary study completion. Here is what sponsors should change—and one important detail about what is guidance versus law.

byGRC Times
FDA ComplianceClinical TrialHealthcare

FDA Just Finalized How Sponsors Should Prepare for Formal Meetings

FDA published final guidance on August 13, 2026 covering formal meetings between FDA and sponsors or applicants of products subject to the Prescription Drug User Fee Act. It applies to drug and biological products regulated by CDER and CBER and finalizes the draft issued in September 2023. This is guidance,…

byGRC Times
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