Rachel Irving Pitts

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Latest Posts › Food and Drug Administration (FDA)

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Health Care Weekly Preview from ML Strategies – May 2017

We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User...more

5/23/2017 / Affordable Care Act , American Health Care Act (AHCA) , Chronic Care Managment (CCM) , Food and Drug Administration (FDA) , Healthcare Reform , Legislative Riders , Medicare , Minibus , Proposed Legislation , User Fees

Opioids, FDA and Medicare Advantage Spending on the List for Congress

As Congress is back to Washington for its next work period, ML Strategies has published an Advisory outlining health care issues on the radar for the upcoming weeks. Highlights include: legislative initiatives on opioid...more

2/24/2016 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Legislative Agendas , Medicare , Medicare Advantage , Mental Health , Substance Abuse

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

1/28/2016 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HELP , Hospitals , Medical Devices , Patient Safety , Prescription Drugs

FDA’s New Four-Letter Guidance on Biosimilars

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products....more

9/1/2015 / Biologics , Biosimilars , Comment Period , Draft Guidance , Federal Register , Food and Drug Administration (FDA)

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