Monthly Archives

June 2020

FDA issues final guidance on inspections of medical device establishments

By FDA News

FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

Fast facts

”The US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).

The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspections. (RELATED: FDA Drafts Guidance on Inspections of Medical Device Establishments, Regulatory Focus 28 March 2019)”
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CBP Continues to Seize Large Number of Counterfeit and Unapproved COVID-19 Products

By FDA News

FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

Fast facts

WASHINGTON — U.S. Customs and Border Protection (CBP) continues to identify and seize a large number of counterfeit, unapproved or otherwise substandard COVID-19 products that threaten the health and safety of American consumers.

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Mortality Outcomes of Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures

By Latest News

Fast facts

In a meta-analysis of more than 2 million patients, those with osteoporotic vertebral compression fractures who underwent vertebral augmentation were 22% less likely to die at up to 10 years after treatment than those who received nonsurgical treatment, RSNA 2020

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