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FDA Clears Teleflex Arrow Hemodialysis Catheter

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Clears Quest Genital Swab Claim for Herpes Test

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Amgen Loses Bid to Delay Sandoz Biosimilar Launch

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Amgen loses its bid to delay Sandozs market introduction of the first biosimilar product approved in the U.S. a copy of Amgens Ne...

FDA Releasing More Medical Device Info

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CDRH says it has released much more medical device information through its openFDA program that may help spur innovation and scien...

CDER/DIA Meeting on Oligonucleotide-Based Therapeutics

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Federal Register notice: CDER cosponsors with the Drug Information Association a meeting entitled FDA/DIA Oligonucleotide-Based Th...