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Regulatory Compliance

FDA Guidance Provides Relief for MDR Reporting During a Pandemic

Exeed Regulatory Compliance

MARCH 22, 2020

Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic. Adverse event reporting requirements are very stringent, and late reporting of such events is a routine focus of FDA inspections and subsequent warning letters.

FDA

FDA Nursing Homes Compliance COVID-19

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA

FDA US Department of Health and Human Services COVID-19 Informed Consent

FDA Guidance Provides Relief for MDR Reporting During a Pandemic

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

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