Newsletter - July 18, 2019
FDA and EU Finish cGMP Inspection Integration
As of last week, FDA has fully implemented its Mutual Recognition Agreement (MRA) with the European Union (EU) whereby FDA and regulators from all 28 member countries of the EU would share GMP inspection findings at drug manufacturing sites. The MRA is but the first step. Read More
Diagnostic Errors Are Mostly Due to Clinical Judgement: Opportunity for AI
A recent study reported that almost 90% of diagnostic errors cases are attributed to errors in clinical judgement by physicians in outpatient settings. These findings have a strong implication for developers of AI algorithms to automate diagnosis aiming to reduce human errors. Read More
FDA and EU Finish cGMP Inspection Integration
As of last week, FDA has fully implemented its Mutual Recognition Agreement (MRA) with the European Union (EU) whereby FDA and regulators from all 28 member countries of the EU would share GMP inspection findings at drug manufacturing sites. The MRA is but the first step. Read More
Diagnostic Errors Are Mostly Due to Clinical Judgement: Opportunity for AI
A recent study reported that almost 90% of diagnostic errors cases are attributed to errors in clinical judgement by physicians in outpatient settings. These findings have a strong implication for developers of AI algorithms to automate diagnosis aiming to reduce human errors. Read More
