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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations, including RDC 16/2013 and IN 08/2013, and went into effect on 02 May 2022. The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements.

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Health Provider News

Hall Render

Care Taps Health Net Exec as New CEO COLORADO Aurora’s Fitzsimons plans development opportunities on 60 acres Boulder drug discovery co. 3 in the U.S. for maternity care Healthcare Shifts Driving Demand For Outpatient Facilities In Denver Insider Breach, Email Attacks Net $1.7M

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Health Provider News – July 22, 2022

Hall Render

Director says multiple Arizona nursing homes had around 300 complaints. ESI Closes on 280-Bed SNF Sale; Blueprint Secures Deal for Connecticut Nursing Home. The Journey from Nursing to COO of John Dempsey Hospital. Illinois nursing home closes its doors after 70 years. Iowa physicians sell $16.4M

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

Drug & Device Law

Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. The G/N MDL was created in 2013 and mostly settled in 2016. That makes Hrymoc a one-off exception from a general exclusion of §510(k) evidence. 3d , 2023 WL 5807340 (D.

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