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Guidance on Device Establishment Registration

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Federal Register Notice: FDA releases a guidance on implementing medical device establishment registration and device listing requ...

NIOSH Hazardous Drugs List Being Revised with FDA Data

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The National Institute for Occupational Safety and Health says it is using FDA approval information to revise its list of drugs co...

Advisors Support Broader Selzentry Indication

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FDAs Antiviral Drugs Advisory Committee recommends that FDA approve a broader indication for Pfizers HIV drug Selzentry.

FDA OKs APP Pharmas Generic Imitrex

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FDA approves an APP Pharmaceuticals ANDA for a generic copy of GlaxoSmithKlines migraine drug Imitrex injection in two dosage stre...

Latest FDA-483s, EIRs, Etc. Posted

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We post to our Web site latest FDA-483s, EIRs received from FDA pursuant to our FOIA requests, for Mark Adams, MD; Custom Ultrason...

Framework of Policy Seen in Retrospective Genomic Data

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CDERs Lawrence Lesko says the way in which Amgen and BMS/Imclone approached retrospective analysis of trial data for relabeling th...

FDA Looking to Free Resources for Company Innovation

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FDA commissioner Margaret Hamburg says the agency wants to find ways to save regulated companies some money that they can invest i...

FDAs ReGen Re-review Pinches Companys Cash

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ReGen Biologics says FDAs decision to re-review its Menaflex 510(k) clearance has hurt the companys ability to raise operating cas...