1. FDA Publishes Fiscal Year 2017 User Fee Rates

    The Food & Drug Administration (FDA) published its application fee for Prescription Drug User Fee Rates for Fiscal Year 2017 and Biosimilar User Fee Rates for Fiscal Year 2017. According to the notice, the FDA is lowering the fees companies will pay for prescription drug and biosimilar user fees next year to at $2.038 million. The new rates will take effect October 1, 2016.

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  2. USP Letter on Biologics

    The United States Pharmacopeia (USP) requested NCPDP’s support in responding to a provision relating to biologics included in the Senate Health, Education, Labor & Education (HELP) Committee Medical Innovation Package. The provision would exempt biological medicines from the requirement to adhere to USP public standards for quality. NCPDP agrees that, if enacted, this provision would have potentially grave consequences for public health and safety. NCPDP is an Observer Organizational Member of USP and shares a common vision for patient safety.

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  3. Building a Common REMS Platform

    The Duke-Margolis Center for Health Policy invites you to attend a public workshop entitled, “Building a Common REMS Platform,” which will take place on June 7, 2016, at Hotel Monaco in Washington, D.C.

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  4. CDC Publishes Guidelines for Opioids for Chronic Pain

    The Center for Disease Control and Prevention (CDC) published the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain this week. According to the CDC, the guidelines “aim to provide safer, more effective care for patients with chronic pain, and ultimately reduce prescription opioid use disorder and overdose.” The agency says new CDC guidelines stress that other methods of treating pain should be preferred to opioids. When the drugs are used, it should be in the lowest possible doses. 

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  5. SAMHSA Notice of NPRM

    The U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a notice of proposed rulemaking (NPRM modifying 42 CFR Part 2, referred to as Part 2), pertaining to the confidentiality of substance abuse treatment records.

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