The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
These companies must pass FDA compliance inspections (audits) to 21 CFR 820. One of the key components of these device CGMPs is addressing post-market use issues and complaints/CAPA. The FDA ...
The FDA criticized Hologic’s corrective and preventive action procedures, citing delayed responses to recurring adverse events such as infections, tissue damage, and device migration.
In the fast-paced manufacturing industry, continuous improvement and process optimization are indispensable strategies for ...
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
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Os ensaios clínicos pioneiros no campo dos xenotransplantes começarão nos EUA ainda este ano; entenda.Os testes em questão envolvem o transplante de rins de porcos geneticamente modificados em humanos. O primeiro estudo será ...
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...
Two top clinicians have been disciplined amid growing concern that Kaiser’s system for monitoring research safety and ethics ...
US President Donald Trump’s executive order on the review of United States Agency for Inter-national Development (USAID) aid ...
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