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Unpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment

Health Law Advisor

The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. Product codes are the language of FDA regulation. Every medical device FDA regulates is placed into a product code.

FDA 98
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How to Achieve Health Equity in Decentralized Clinical Trials

HIT Consultant

The community category included ambassador programs and work with community advisors. It begs the question: how do we ultimately achieve full representation and ensure accountability to uphold the promises we have made for patients?

FDA 98
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GOP House Opens With Abortion Agenda

Kaiser Health News

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.