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FDA Renews Charter for Non-Rx Drugs Advisory Committee

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Federal Register notice: FDA renews for two years the charter for the Nonprescription Drugs Advisory Committee.

FDA Withdraws Guide on Medical Gas Warning Letters

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Federal Register notice: FDA withdraws Compliance Policy Guide Section 435.100, entitled Compressed Medical Gases Warning Letters...

Omeros Files Patent Infringement Suit Against Par

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Omeros Corp. files patent infringement lawsuits against Par Pharmaceutical and Par Sterile Products related to Omeross drug Omidri...

FDA Clears Teleflex Arrow Hemodialysis Catheter

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FDA clears a Teleflex 510(k) to market its Arrow Triple Lumen Pressure Injectable Acute Hemodialysis Catheter that is intended to ...

FDA Finds 11 Violations at US Compounding

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An FDA inspection at US Compounding identifies 11 violations listed on an FDA-483.

FDA Clears Quest Genital Swab Claim for Herpes Test

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FDA clears a Quest Diagnostics 510(k) to add a genital swab claim to its Simplexa HSV (herpes simplex virus) 1 & 2 Direct molecula...

Argument for Bayesian Analysis of Drug Trials

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MIT researchers say a Bayesian decision analysis framework can be used to incorporate all stakeholders views in a systematic, tran...

Experts Disagree on Tough Regulatory Standards

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U.S. and European stakeholders debate the value and adverse consequences of strict drug and medical device evaluation and approval...

Tesaros Verubi Approved for Chemo-related Nausea

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FDA approves Waltham, MA-based Tesaro Inc.s Varubi (rolapitant) for preventing delayed phase chemotherapy-induced nausea and vomit...

Covidien Recalls Ventilators Due to Software Error

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Covidien recalls its Puritan Bennett 980 Ventilators due to a software error that may affect the amount of air delivered to patien...