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FDA Seeks Participants for Biosimilar Act Reauthorization

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Federal Register Notice: FDA request that drug companies and trade associations notify the agency of an intent to participate in t...

Medtronic PMA Approved for Bladder/Bowel Evaluations

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FDA approves a Medtronic PMA for the Verify Evaluation System for use in making basic bladder/bowel evaluations, which last up to ...

FDA Social Media Rules Violate 1st Amendment: WLF

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Washington Legal Foundation says FDA should consider that a successful First Amendment challenge is likely against its social medi...

Pew Warns Against Expanding Animal Antibiotic OKs

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The Pew Charitable Trusts says FDA should not expand conditional approvals for antibiotics beyond minor species or minor uses in m...

QS, MDR Violations Found in Ultroid Inspection

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FDAs Florida District Office warns Ultroid Technologies about QS and MDR violations in its manufacturing of a misbranded hemorrhoi...

Microport Ortho Recall Profemur Hip Prosthesis

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MicroPort Orthopedics begins a Class 1 recall of the Profemur Plus Cocr Modular Neck orthopedic hip prosthesis component due to an...

Tighten Animal Drug Compounding Oversight: GAO

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A new Government Accountability Office report recommends that FDA improve its oversight of drug compounding for animal use.

Court Affirms Most of Shire Vyvanse Decision

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A federal appeals court backs a lower court decision on two key elements in a case involving disputed patents for Shires Vyvanse.

Many Devices Exposed to Online Hacking: Report

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UK researchers say many healthcare organizations are exposed to cyber hacking of their medical device systems.

Medsource Inspection Finds QS Violations

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FDAs New England District Office warns Medsource about Quality System regulation and other violations.