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BodyGuard Infusion Sets Recalled

[ Price : $8.95]

CME America recalls its BodyGuard Microset Infusion Sets due to potential medication flow restrictions.

FDA Postpones Domestic Surveillance Inspections

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Due to coronavirus concerns, FDA temporarily postpones all domestic routine surveillance facility inspections due to agency staff ...

Conducting Clinical Trials During Pandemic

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FDA says a guidance on conducting clinical trials during the Covid-19 pandemic takes effect immediately.

FDA Loses Eagle Orphan Drug Appeal

[ Price : $8.95]

The DC Circuit Court of Appeals rules against FDA in a suit challenging the agencys denial of orphan drug exclusivity for Eagles B...

More Pediatric Oncology Guidance Info Sought

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Two drug trade associations suggest ways FDA could improve a draft question-and-answer guidance on pediatric study plans for oncol...

Data Reporting Case Analyzed

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Ropes & Gray analyzes a federal court decision that could force companies to submit 10 years worth of clinical trial results to Cl...

Guide on Liquid Drug Flow Restrictors

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Federal Register notice: FDA makes available a draft guidance entitled Restricted Delivery Systems: Flow Restrictors for Oral Liqu...

Preemption Cited in Gadolinium Case

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Attorney Steven Boranian says a Louisiana federal court decision to dismiss state law claims against a gadolinium contrast manufac...

Lewicki Debarred for 5 Years

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Federal Register notice: FDA debars Jagen Lewicki for five years from importing or offering for import any drug into the U.S.

Daily Debarred for Illegal Kratom Imports

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Federal Register notice: FDA debars Matthew Dailey for 10 years from importing or offering for import any drug into the U.S.