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Risk Mitigation Informed Consent Food and Drug Administration (FDA)

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Harris Beach PLLC

FDA Issues Warning for Robotically Assisted Mastectomies and Other Cancer Surgeries

Harris Beach PLLC on

The Food and Drug Administration (FDA) has issued a safety warning regarding the use of robotically assisted surgical devices for mastectomies and other cancer surgeries, asserting that "the safety and effectiveness of...more

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