FDA 483 - David Gerber, M.D. - August 19, 2019
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David Gerber, M.D., a clinical investigator in Dallas, TX, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, including issues with timely IRB reporting, screening assessments, and treatment protocols. Additionally, the inspection revealed a failure to promptly report serious adverse events (SAEs) to the sponsor and ensure timely investigator review.
ID · 7301a502-d5f1-44b3-967b-311e23ce00b1