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TMJ Implants Loses on All Counts to FDA

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Embattled Colorado medical device maker TMJ Implants Inc. loses its final FDA battle in the U.S. Court of Appeals for Tenth Circui...

Republicans Draft Debarment Bill

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Rep. Joe Barton and other House Energy and Commerce Committee Republicans draft legislation to strengthen FDAs ability to quickly ...

DDMAC Cites Sanofi-Aventis Promo

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DDMAC cites a Sanofi-Aventis voucher tent card for Uroxatral, saying it is misleading and fails to present its indication despite ...

Zinecard Now Available

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FDA says that the shortage of Pfizers Zinecard has been resolved.

FDA Can Improve Device Adverse Event Reporting: OIG

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The HHS Inspector General says that CDRH doesnt adequately review and respond to medical device adverse event reports.

FDA Clears Lumenis Flexible Endoscope

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FDA clears a Lumenis 510(k) for the PolyScope Flexible Endoscope, intended for use in flexible endoscopic procedures for diagnosti...

Pediatric Oncology Panel to Meet

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 12/15 to discuss developing pediatric cancer drugs and dos...

FDA Withdraws Product from OTC Monograph Consideration

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Federal Register Notice: FDA withdraws notice of eligibility for S. boulardii to be considered for the OTC monograph for antidiarr...

SPL Labeling Content Standard Guidance Out

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FDA issues the first revision of a 2005 guidance on using the SPL standard for labeling content.