1. FDA Biosimilar Naming Guidance and Proposed Rule

    The Food & Drug Administration (FDA) released draft guidance and a related proposed rule on the naming of biologic drugs and biosimilars. The draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names in the guidance) that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product. This suffix would be composed of four lowercase letters that won't carry any meaning.

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  2. 340B Omnibus Guidance Proposed

    The Department of Health & Human Services (HHS) published its much anticipated draft omnibus guidance on the 340B program.  The draft guidance is intended for covered entities, such as hospitals and certain clinics, enrolled in the 340B program and the drug manufacturers that are required to provide discounts on outpatient drugs.

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  3. CMS Publishes Memo

    The Centers for Medicare & Medicaid Services (CMS) recently published a memo entitled "Compliance With Any Willing Pharmacy (AWP) Requirements." The memo discusses guidance on complying with the AWP requirement.  According to CMS, the memo is in response to concerns with the “process some Part D sponsors have adopted for complying with the AWP requirement, particularly issues with transparency and timing of sponsors’ AWP contracting processes, as well as the content of their standard terms and conditions.”

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  4. ONC Hosting Webinar

    The ONC is hosting the ninth webinar of a 10-part series on health IT and patient safety, “Information Transparency and Health IT Safety” on August 20, 2015 from 1:00 p.m. - 2:30 p.m. EST. The webinar will feature perspectives on information transparency and health IT safety from the viewpoints of the patient, the practitioner, leaders of health systems improvement, and policymakers. Slides and audio of previous webinars in this series are also now available.

    Register today.

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  5. HHS Announces New Initiatives

    Health & Human Services (HHS) Secretary Burwell announced new initiatives to combat opioid abuse and expanding treatment and services for substance abuse. Included in the announcement, HHS states that the agency is making additional funding available to states and community health centers to expand the use of medication-assisted treatment for opioid use disorder, and is releasing guidance to help states implement innovative approaches to substance use disorder treatment.

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