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Individual Case Safety Report Guidance

[ Price : $8.95]

FDA publishes an ICH guidance on electronic transmission of individual case safety reports.

Abbott Holding $1.5 Billion for Possible Depakote Settlement

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Abbott discloses a $1.5 billion litigation reserve for use in a possible settlement with the Justice Department of charges that it...

FDA to Amend Orphan Drug Regulations

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Federal Register Proposed rule: FDA proposes to amend the orphan drug regulations to clarify certain provisions and make minor imp...

Panel to Discuss Organogenesis BLA

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Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/17 to discuss an Organogenesis B...

FDA Corrects Withdrawal of Pfizers Geocillin

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Federal Register Notice: FDA corrects an inadvertent withdrawal of approval of Pfizers Geocillin.

FDA Proposes Orphan Drug Clarifications and Changes

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FDA lists 13 changes and clarifications it proposes making to the current orphan drug regulation.

FDA Clears Crospon Endoscopic Accessory

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FDA clears a Crospon 510(k) for its EF-800 external channel endoscopic accessory.

Could Par Suit be 'Leverage' Attempt in Gov't Probe?

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FDA observer and attorney Arnie Friede says Par's recent First Amendment suit against the agency appears to be an attempt to gain ...

MDR Violations Found at Respironics

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FDAs Philadelphia District Office warns Respironics about Medical Device Reporting violations in its manufacturing of continuous v...

Post-marketing ADE Reporting Problems at Jazz

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FDAs San Francisco District Office warns Jazz Pharmaceuticals about adverse drug experience reporting violations.