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Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

OCR Issues Updated Guidance on “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates”

The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) recently released a revised version of its guidance titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business...more

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