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FDA Seeks Advisory Panel Selectors, Consumer Nominations

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Federal Register Notice: FDA seeks consumer organizations to aid in selecting representatives to serve on its advisory committees ...

Cancer Assay Gets Parallel Review at FDA/CMS

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FDA and the Centers for Medicare and Medicaid Services accept a Foundation Medicine PMA for FoundationOne for a parallel review in...

Device Company Charged with Fraud in Grants Case

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The Justice Department files suit against Jerome Hahn (Lexington, KY) and a medical device company he owns, Telehealth Holdings, f...

CDRH Guidance on Small Business User Fees

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CDRH posts a guidance on FY 2017 Medical Device User Fee Small Business Qualification and Certification that describes the process...

FDA Approves Dysport for Pediatric Lower Limb Spasticity

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FDA approves an Ipsen sBLA for Dysport (abobotulinumtoxinA) for injection for treating pediatric lower limb spasticity in children...

University of Michigan Gets 8-item 483 After June Inspection

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FDA issues the University of Michigan an eight-observation Form-483 about pharmacy compounding violations it observed during a Jun...

FDA Piloting New Combination Product Consult Process

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FDA officials say the agency will begin piloting a new inter-Center consult request procedure for proposed combination products.

Sage Recalls 1 Lot of Comfort Shield Cloths

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Sage Products recalls one lot of Comfort Shield Barrier Cream Cloths due to contamination (Burkholderia cepacia) concerns.

FDA Sets Fees for Outsource Drug Compounders

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Federal Register Notice: FDA announces the rates for the establishment and re-inspection fees related to entities that compound hu...

Info on Tobacco Training Programs Guidance Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on tobacco retailer training programs to t...