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Pharma Sales Rep Pleads Guilty to Healthcare Fraud and Criminal HIPAA Violations

HIPAA Journal

A pharmaceutical sales rep has pleaded guilty to conspiring to commit healthcare fraud and wrongfully disclosing and obtaining patients’ protected health information in an elaborate healthcare fraud scheme involving criminal HIPAA violations. He is due to be sentenced on Feb.

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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 113
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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60
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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60
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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60
article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60
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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). As such, manufacturers and importers that have already submitted their applications to CDSCO may continue marketing their devices in India as they prepare for compliance.

FDA 52