FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Latest FDA-483s, EIRs, Etc. Posted

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Potential Risks Identified in 13 Products in 1st Quarter

[ Price : $8.95]

FDA says that it identified potential signals of serious risks or new safety information in 13 drugs during the first quarter of t...

Device Registration, Listing Guidance Out

[ Price : $8.95]

CDRH issues a guidance on changes in the medical device registration and listing program.

Guidance on Device Establishment Registration

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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