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Adverse Events Health Care Providers

K&L Gates LLP

COVID-19: FDA Warning Letters Address Fraudulent Products and Failures to Meet EUA Requirements

K&L Gates LLP on

In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Florida Supreme Court Broadens Patient Access to Adverse Incident Reports

A recent decision by the Florida Supreme Court has significant implications regarding certain adverse incident reports previously viewed as outside the scope of permitted discovery. Florida health care providers currently...more

Dorsey & Whitney LLP

Medical Liability Reform – Iowa’s Communication and Optimal Resolution (Candor) Bill Effective July 1, 2015

Dorsey & Whitney LLP on

On July 1, 2015, the Iowa legislature rolled out what is being heralded as its most significant medical liability reform of the past decade: enabling confidential “open discussions” between health care providers and patients...more

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