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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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
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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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
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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

Health Law Advisor

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

The CMDE published additional documents (link in Chinese) that outline the recommended paths for clinical evaluation of certain devices under select sub-categories of the Medical Device Classification Catalog. 26 of 2014. United States Food and Drug Administration (FDA) – Regulations and guidance. CMDE Announcement No.

FDA 40