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FDA Clears St. Jude Ilumien System

[ Price : $8.95]

FDA clears a St. Jude Medical 510(k) for its Ilumien system, an integrated diagnostic technology intended to help improve coronary...

Errors Corrected in FDA/CMS Device Pilot Program

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Federal Register Notice: FDA corrects a Web and e-mail address in a Federal Register notice seeking device sponsors to participate...

FDA Posts Two Hospira 483s; Company Reports Loss

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FDA posts two FDA-483 inspection reports for a troubled Hospira manufacturing plant while the company updates financial analysts o...

FDAs Newest Deputy Chief Vows Not to Micromanage Centers

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Newly-appointed FDA deputy commissioner for medical products and tobacco Stephen Spielberg explains he does not intend to microman...

Justice Dept. Joins HHS in Formalizing Info Power Grabs

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The Department of Justice takes parallel action to a controversial HHS news media policy by also formalizing a longestablished inf...

Coalition Wants Changes to FDA Mobile Medical Apps Guidance

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The mHealth Regulatory Coalition suggests topics needing more FDA attention as it finalizes a guidance on mobile health applicatio...

FDA Seeks to Reassess Bar Code Rule

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Federal Register Notice: FDA establishes a public docket to receive information to help it reassess the 2004 final rule requiring ...

Documents Out on Electronic CTD Submissions

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Federal Register Notice: FDA releases draft versions of documents that support making submissions using the electronic Common Tech...

FDA Debars Cioffi

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Federal Register Notice: FDA issues an order debarring Albert Cioffi MD for five years from providing services to any person with ...

Amgen Says Marketing Suits Settlement Near

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Amgen says it is taking a $780 million third quarter charge in anticipation of a settlement agreement on 10 whistleblower suits in...