Precautions for securing a trial’s investigational drug(s) must be ironclad in the eyes of the FDA, and corrective and preventive actions enacted when these safeguards are absent or compromised must be just as rigorous, a recent FDA warning letter illustrates.
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The FDA and NIH are asking stakeholders for support in developing a glossary of terms related to clinical trial innovation, especially terms involving use of real-world data (RWD) and real-world evidence (RWE).
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This week’s Pipeline features a phase 2 trial approval for obesity, a phase 3 trial start for dry eye disease and an FDA approval for a noninvasive colorectal cancer screening test.
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