Legislative News

  1. FDA Publishes Communication Guidance on Drug Development

    The Food & Drug Administration (FDA) recently published draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development: Guidance for Industry and Review Staff.” According to the FDA, the guidance is a joint effort by the agency’s drug and biologics centers to describe “timely, transparent, and effective communications” in an effort to bring safe and effective drugs to the public sooner. The draft guidance addresses: 

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  2. SCOTUS: Healthcare Fraud

    The Supreme Court announced it will take up Universal Health Services v. United States ex rel Escobar. The case focuses on the submission of fraudulent bills to government agencies for services that were not actually performed. Modern Healthcare reports on the implications of the case to the healthcare industry.

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  3. Compounding Drugs Active Ingredient List

    The FDA is developing a list of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with the FD&C Act. The FDA previously solicited nominations for the list, but some of the nominated substances were not supported by sufficient information for the FDA to evaluate them. The FDA is establishing a public docket where these substances can be renominated with sufficient supporting information or to receive nominations of bulk drug substances that were not previously nominated for consideration for inclusion on the 503B bulks list. Comments can be submitted at any time.

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  4. GAO Report on EHRs

    A new U.S. Government Accountability Office (GAO) report outlines five key obstacles to achieving interoperability. GAO  interviewed representatives from 18 selected unidentified, nonfederal initiatives aimed at advancing interoperability, and their approaches to achieving interoperability. Read the full report

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  5. ONC Publishes Health IT Strategic Plan 2015-2020

    The Office of the National Coordinator (ONC) released the revamped version of the Health IT Strategic Plan 2015-2020. According to the ONC, this is a blueprint to improve the health IT infrastructure to help transform healthcare delivery, improve individual and community health and support a responsive, evolving health IT ecosystem that puts individuals at the center of care.

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