Michael Mezher

The International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents detailing guiding principles for good machine learning practices (GM...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. Th...

Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. There@s a lot to unpack from the past week @ the election of Donald Trump to serve a second term as president has massive implications for both FDA and the regulated industry, though despite some incendiary comments about what@s to come, much remains to be seen about how the incoming administration will act.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. Th...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. Th...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. Th...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. Th...

The US Food and Drug Administration wants stakeholder feedback on its integrated assessment and integrated review documentation for new drugs as part of its New Drugs Regulatory Program Modern...

India’s Central Drugs Standard Control Organization (CDSCO) earlier this month announced that it will waive local clinical trial requirements for certain drugs approved in other countries.

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