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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. China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 19 Medical Rehabilitation Equipment.

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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.

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Another Update on Medical Abortion Litigation

Drug & Device Law

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

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Another Update on Medical Abortion Litigation

Drug & Device Law

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

FDA 52