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SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

ANVISA published the RDC 702/2022, which repeals some requirements that were instituted to speed market approval of devices needed to treat patients during the height of the COVID-19 pandemic. The Agency recently published the first list of critical medicines for the management of the COVID-19 pandemic.

FDA 91
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. 19 Medical Rehabilitation Equipment. Medicine shortages and reduced availability of medicine represent an increasing issue across the European Union (EU) and the globe, which has been amplified by the COVID-19 pandemic.

FDA 40
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A Texas Mess

Drug & Device Law

So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19. The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. FDA (8/23/21) press release (emphasis original).