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FDA Hires CRO for Adverse Event Surveillance Review

[ Price : $8.95]

FDA hires PPD, Inc. to evaluate CDERs post-approval spontaneous adverse event surveillance system.

FDA Clears Influenza Virus Detection Kit

[ Price : $8.95]

FDA clears a Diagnostic Hybrids 510(k) clearance for the D(3) FastPoint L-DFA Influenza A/ Influenza B Virus Identification Kit.

Latest Sidewiki Technology Can Create More FDA Questions

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Attorney Arnold Friede urges FDA to address legal liability questions arising out of Sidewikis appearing on drug company home page...

Revised Guidance on Structured Product Labeling

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Federal Register Notice: FDA releases a draft revised guidance, SPL Standard for Content of Labeling Technical Qs & As.

Science Advisory Board to Toxicological Center to Meet

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Federal Register Notice: FDAs Science Advisory Board to the National Center for Toxicological Research will meet 11/17-18 to provi...

Drug Companies Should Worry About WV Policy

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Attorneys James Beck and Mark Herrmann say a recent West Virginia federal court decision raises problems for drug companies due to...

FDA Clears Faster AdvanDx FISH Test

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FDA clears an AdvanDx 510(k) for a 90-minute protocol for its E. faecalis/other enterococi PNA FISH test.

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

[ Price : $8.95]

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