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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.

FDA Clears Spineology Rampart Fusion Implants

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FDA clears a Spineology 510(k) for its Rampart Interbody fusion implants.

Quality Problems Found in SKB England Facility

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FDA warns SmithKline Beecham of CGMP problems at a UK drug manufacturing plant.

Republican Lawmakers Introduce 10 CDRH Reform Bills

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House Energy and Commerce Committee Republicans introduce 10 bills they say will improve predictability, consistency, and transpar...

OGD Question-based Review for Sterility

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CDERs Office of Generic Drugs develops a question-based review module for Sterility Assurance Quality Overall Summary (SA-QOS) Ou...

FDA Finds 48 Quality Issues at Ben Venue

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FDA issues the FDA-483 from a May inspection at Ben Venue Laboratories detailing 48 quality concerns in the firms contract manufac...