FDA

In the News: Specialty Drugs Fill 2017 Pipeline

New therapies to treat inflammatory conditions, multiple sclerosis, and cancer are among the products highlighted in Express Scripts’ Specialty Pipeline report. In 2016, specialty drugs made up 71% of the 24 drugs approved by the FDA last year. That trend is expected to continue, with specialty drugs, including therapies for orphan diseases, dominating the 2017 pipeline.

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E2B Gateway Speeds AE Submissions to Regulatory Authorities

Our Argus Safety Team recently worked with the FDA to implement an E2B Gateway which allows our global safety team to submit clinical trial individual case safety reports electronically.  This provides a means of compliant filing which alleviates time pressure, allowing safety scientists and the medical review teams to do what they do best -- evaluate Adverse Event reports. The Pharmacovigilance staff also can process more reports in less time, allowing for increased time for medical review and setting the stage for increased case volume potential.

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The Evolving Post-Marketing World: Key Takeaways from ISPOR 16th Annual European Congress

ISPOR 16th Annual European Congress, held November 2-6 in Dublin, was a great success, providing the opportunity for thought-provoking presentations as well as valuable networking and information sharing.

Industry thought leaders participated in a panel that explored patient-reported outcomes and how best to incorporate them in EMA and FDA safety mandates. Additionally, our UBC experts presented a number of abstracts throughout the conferences.

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REMS Experience Counts

We’ve heard from pharmaceutical manufacturer sponsors that the thought of having the FDA mandate a Single Shared System REMS on their product gives them nightmares.   Well, we’re here to tell you, there’s no need to lose sleep. 

In 2010, the FDA initiated a Single Shared System REMS for certain drug classes that involve multiple products by multiple manufacturers.  And, since that time, UBC has been a part of every Single Shared System REMS program. 

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The "Eyes" Have It

The Federal Drug Administration (FDA) Safety and Innovation Act moved one step closer to final approval this week when it was passed by Congress.  The bill is expected to be signed into law by President Obama later this summer.

The intent of the bill is to continue the agency’s mission to protect and promote the public health.

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