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CDRH Opted to Redact Info from Public Comments

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CDRH says it opted to redact sender identification and other information from public comments on LASIK safety out of concern for p...

List of Approved PMAs Posted

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Federal Register Notice: FDA publishes a list of approved PMAs and to inform the public of the availability of safety and effectiv...

Oxygen Storage Tanks Recalled

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Pacific Consolidated Industries recalls mobile oxygen storage tanks that pose a fire hazard if the pressure gauge ruptures.

FDA Moves to Risk-based Guides While 314.70 is Rewritten

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CDER Office of Pharmaceutical Science policy associate director Jon Clark tells a GMP conference that the agency is issuing risk-b...

Latest FDA-483s, Correspondence Posted

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FDA Webview posts to our site the latest 15 FDA-483s and related correspondence that we have received from FDA pursuant to our FOI...

GVAX VITAL-2 Trial Halted

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Cell Genesys teminates its VITAL-2 test of GVAX and Taxotere in advanced prostate cancer due to a significant number of deaths in ...

ORA Revitalization: Slow or No Progress, or No Transparency?

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Consulting editor John Scharmann checks on the progress of ORAs Revitalization effort after nearly six months, and finds little to...