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Risk Management › Patient Safety › Regulatory Requirements

Gardner Law

Product Liability Prevention: A Proactive Approach for FDA-Regulated Industries

Gardner Law on

Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more

Foley & Lardner LLP

FDA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more

Goodell, DeVries, Leech & Dann, LLP

Understanding CMS “Immediate Jeopardy” Investigations in Healthcare Facilities

Goodell, DeVries, Leech & Dann, LLP on

When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more

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